An interventional study of Lpc-37 and Placebo in Healthy and Stress, Psychological, sponsored by Daacro. Completed at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Daacro · Not applicable, Interventional, and Basic science
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Among 27 studies in Stress, Psychological with a site in Germany — 6 open to participants now, 7 under way, none of them phase 3. Stress, Psychological · Germany.
Among the 27 studies in Stress, Psychological with a site in Germany, this one is the 7th largest by enrollment of the 19 interventional ones that give a count, is one of 4 that started in 2018, is one of 19 with no phase, and was the 8th registered.
848 studies on the registry are indexed under Stress, Psychological; 139 are open to participants now.
Browse Stress, Psychological studies →6 of the 27 studies in Stress, Psychological with a site in Germany are open now. Recruiting first, the newest first:
University of Cologne · Sites in Germany
Ages 1 days–7 days · Healthy volunteers
Charite University, Berlin, Germany · Sites in Germany
Ages 18+ · Healthy volunteers
University Hospital Augsburg · Sites in Germany
Ages 18+
Charite University, Berlin, Germany · Sites in Germany
Ages 18–70
University Hospital, Aachen · Sites in Germany
Ages 18+ · Healthy volunteers
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 75 Stress, Psychological studies recruiting now, 34 (45%) set no upper age limit and 37 (49%) stop at 75 or younger; 14 take children under 18; 49 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
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27 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2018.
This study's enrollment of 120 is above the median of 84 across 692 interventional studies indexed under Stress, Psychological.
Median enrollment 90 across the 19 interventional studies, 207 across the 8 observational. Of the 17 that completed or were terminated, 1 (6%) have results posted.
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None of the 27 has an industry lead sponsor. The 10 most frequent:
Daacro is the lead sponsor of 4 studies on the registry; none are open to participants now.
Daacro has 2 studies filed under Stress, Psychological — fewer than ten, so there is no comparison to draw.
1 of the studies in Stress, Psychological with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07607808University Hospital, AachenPsychological Stress and Support Needs of Volunteer First Responders After Smartphone-based Cardiac Arrest Alerts | 2027-05-01 |
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Among the 27 studies in Stress, Psychological with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this study is to assess whether a 5 week intake of a probiotic (Lpc-37) can modulate stress and anxiety experienced by healthy subjects during and after an acute stressor compared to placebo. To measure stress and anxiety, markers of the hypothalamic-pituitary-adrenal (HPA) axis activity and questionnaires will be assessed before, during and after the Trier Social Stress Test (TSST). The results of this study indicate if the chosen study design is suitable to discover stress-related effects of probiotics.
The total mass of microorganisms residing within the human intestine is approximately the same as that of the human brain. Of late, these >1000 species and >7000 strains have been described as the "brain in our belly" because of the essential role they play in physiological and psychological health and disease. The gut-brain axis describes the bidirectional communication that exists between the brain and the gut and the microbiota-gut-brain axis supports the role of the gut microbiome in this communication system. Emotional and routine daily life stress can disrupt digestive function, but increasing evidence indicates that the gut microbiota exert a profound influence on brain physiology, psychological responses and ultimately behavior.
A plethora of literature to date, albeit predominantly preclinical, have demonstrated evidence to support the role of the gut microbiome in regulating stress-related changes in physiology, behavior and brain function.
Stress is an individual process to deal with external and internal challenges that ranges from behavioral to molecular adaptations. The HPA axis and its release of stress hormones plays a major role in stress adaptation.
The purpose of this clinical trial is to determine whether a single strain of bacteria derived from the species Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus paracasei Lpc-37, can modulate stress experienced by healthy subjects exposed to the TSST measured by HPA axis activation markers and self-report questionnaires.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus paracasei Lpc-37 1x 1 capsule in the morning for 5 weeks
Dietary Supplement: Lpc-37
Placebo capsule manufactured to mimic Lpc-37 capsule 1x 1 capsule in the morning for 5 weeks
Dietary Supplement: Placebo
Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10\^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide
microcrystalline cellulose, magnesium stearate, silicon dioxide
Change of the Heart Rate (HR) in Response to the Trier Social Stress Test (TSST)
Efficacy was defined as a lower increase in HR in response to the TSST following intervention with Lpc-37, compared to placebo.
Time frame: Continuous measurement starting 20 minutes before and ending 20 minutes after the TSST after 5 weeks of product intake. Mean values were calculated per group at seven-time windows before, during and after the TSST
Changes in Pre and Post Treatment STAI-state Scores
Efficacy of the intake of Lpc-37 on the reduction of State-Trait-Anxiety-Inventory (STAI)-state scores compared to placebo. Measured with the german version of the State-Trait-Anxiety Inventory, scale anxiety as a temporary emotional state (STAI-X1). Answers are given on a four-point rating scale ranging from 1="not at all" to 4="very true". The score range is 20-80; Higher scores indicate more anxiety.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment Perceived Stress Scale (PSS) Scores
Efficacy of the intake of Lpc-37 on the reduction of Perceived Stress Scale (PSS) scores compared to placebo. Measured with the german version of the PSS as a psychological instrument for measuring stress perception. It assesses how unpredictable, uncontrollable and overloaded participants perceived their lives to have been within the last month. The PSS comprises 14 items that are answered on a five-point rating scale ranging from 0 = "never" to 4 = "very often". Individual scores on the PSS can range from 0 to 56 with higher scores indicating higher perceived stress.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment DASS Depression Scores
Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) depression scores compared to placebo. Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content. Items are answered on a four point rating scale ranging from 0 = "not at all" to 3 = "very much". Scores of each scale are calculated by summing the scores for the relevant items. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The items are 3, 5, 10, 13, 16, 17, 21, 24, 26, 31, 34, 37, 38, 42 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment DASS Anxiety Scores
Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) anxiety scores compared to placebo. Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content. Items are answered on a four point rating scale ranging from 0 = "not at all" to 3 = "very much". Scores of each scale are calculated by summing the scores for the relevant items. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The items are 2, 4, 7, 9, 15, 19, 20, 23, 25, 28, 30, 36, 40, 41 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment DASS Stress Scores
Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) stress scores compared to placebo. Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content. Items are answered on a four point rating scale ranging from 0 = "not at all" to 3 = "very much". Scores of each scale are calculated by summing the scores for the relevant items. The stress scale (items) is sensitive to levels of chronic non-specific arousal.The stress scale items are 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment BAI Scores
Efficacy of the intake of Lpc-37 on the reduction of Beck Anxiety Inventory (BAI) scores compared to placebo. Measured with the german version of the Beck Anxiety Inventory as a self-rating scale designed to measure anxiety. It comprises 21 sentences describing feelings that can occur when being anxious. These sentences are rated on a four-point rating scale ranging from 0="not at all" to 3="severely", considering the last 7 days. The score range is 0-63; Higher scores indicate higher anxiety.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment VAS Stress Perception Scores
Efficacy of the intake of Lpc-37 on the reduction of Visual Analog Scale (VAS) stress perception scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating higher perceived stress.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment VAS Anxiety Scores
Efficacy of the intake of Lpc-37 on the reduction of VAS anxiety scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater anxiety.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment VAS Insecurity Scores
Efficacy of the intake of Lpc-37 on the reduction of VAS insecurity scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater insecurity.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment VAS Exhaustion Scores
Efficacy of the intake of Lpc-37 on the reduction of VAS exhaustion scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater exhaustion.
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment Systolic BP
Efficacy of the intake of Lpc-37 on the reduction of systolic blood pressure (BP).
Time frame: Before and after 5 weeks of study product intake.
Changes in Pre and Post Treatment Diastolic BP
Efficacy of the intake of Lpc-37 on the reduction of diastolic BP.
Time frame: Before and after 5 weeks of study product intake.
Change of STAI-State Scores in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of STAI-State scores in response to the TSST compared to placebo. Measured with the german version of the State-Trait-Anxiety Inventory, scale anxiety as a temporary emotional state (STAI-X1). Answers are given on a four-point rating scale ranging from 1="not at all" to 4="very true". The score range is 20-80; Higher scores indicate more anxiety.
Time frame: 10 minutes before the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of Systolic BP in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of the systolic BP in response to the TSST compared to placebo.
Time frame: 3 minutes before the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of Diastolic Blood Pressure (BP) in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of the diastolic BP in response to the TSST compared to placebo.
Time frame: 3 minutes before the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of VAS Stress Perception Scores in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS Stress perception scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating higher perceived stress.
Time frame: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of VAS Anxiety Scores in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS anxiety scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater anxiety.
Time frame: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of VAS Insecurity Scores in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS insecurity scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater insecurity.
Time frame: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of VAS Exhaustion Scores in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS exhaustion scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater exhaustion.
Time frame: 10 minutes before the TSST, during the TSST and 1 minute after the TSST after 5 weeks of study product intake
Change of Salivary Cortisol in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of salivary cortisol in response to the TSST compared to placebo.
Time frame: 1 minute before the TSST and 1, 10, 20, 30 and 45 minutes after the TSST after 5 weeks of study product intake
Change of sAA in Response to the TSST
Efficacy of the intake of Lpc-37 on reduction of the increase of salivary Alpha-Amylase (sAA) in response to the TSST compared to placebo.
Time frame: 1 minute before the TSST and 1, 10, 20, 30 and 45 minutes after the TSST after 5 weeks of study product intake
Change of Sleep Duration Over the Course of the Treatment
Efficacy of the intake of Lpc-37 on the increase of sleep duration over the course of the treatment. Sleep duration was monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Summary measures for Sleep duration for the averaged ratings per participant and week
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
Change of Sleep Related Recovery Scores Over the Course of the Treatment
Efficacy of the intake of Lpc-37 on the increase of sleep related recovery scores over the course of the treatment. Measured with a daily online diary. Sleep related recovery was rated by participants on an 11-point scale (0-10; "not at all" to "very") and monitored throughout the wash-out phase (Week 1 and 2) and the subsequent treatment phase (weeks 3-7). High scores indicate a high recovery. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Summary measures for sleep related recovery for the averaged ratings per participant and week.
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
Change of Reported Sleep Disruptions Over the Course of the Treatment by Week (Proportion Yes/Total)
Efficacy of the intake of Lpc-37 on the decrease of sleep disruptions over the course of the treatment measured with a daily online diary (Proportion (yes/total)). Sleep disruptions were monitored through the wash-out phase and the subsequent treatment phase for each week. In the binary version, the value is either Yes or No for each day and each participant. Efficacy is defined as a decrease, or (in case of a general increase) reduced increase for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. The proportion of participants with at least one sleep disruption by treatment group is given, treatment commenced after week 2. Data listed here reflect the proportion of participants who answered "Yes" (e.g. 0,477 \* 44 = 20.99 participants answered with "Yes" in week 1 in the Lpc-37 group).
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
Change of Reported Number of Sleep Disruptions Over the Course of the Treatment
Efficacy of the intake of Lpc-37 on the decrease of reported number of sleep disruptions over the course of the treatment measured with a daily online diary (mean of week summary). Sleep disruptions were monitored through the wash-out phase (Week 1 and 2) and the subsequent treatment phase (Weeks 3-7). In the count version, the value can be 0 or a natural number for each day and each participant. Efficacy is defined as a decrease, or (in case of a general increase) reduced increase for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Values reflect summary measures for sleep disruptions (count) for the summed counts per participant and week.
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
Change of Perceived Health Status Scores Over the Course of the Treatment
Efficacy of the intake of Lpc-37 on the increase of perceived health status scores over the course of the treatment. Measured with a daily online diary. Health status was rated by participants on an 11-point scale (0-10; "not at all" to "very") and monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a high perceived health.Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Values reflect summary measures for perceived health status on a scale from 0 to 10 for the averaged ratings per participant and week.
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
Change of Mood Scale Scores Over the Course of the Treatment
Efficacy of the intake of Lpc-37 on the increase of mood scale scores over the course of the treatment Measured with a daily online diary. Mood was rated by participants on an 11-point scale (0-10; "very bad" to "very well") and monitored through the washout phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a better mood. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one average value for each week and participant. Values reflect summary measures for mood ratings on a scale from 0 to 10 for the averaged ratings per participant and week.
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
Change of Perceived Productivity Scores Over the Course of the Treatment
Efficacy of the intake of Lpc-37 on the increase of perceived productivity scores over the course of the treatment Measured with a daily online diary. Productivity was rated by participants on an 11-point scale (0-10; "not at all" to "very") and monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a higher perceived productivity. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group.Time is coded as a continuous variable with one value for each day and participant. The values reflect summary measures for perceived productivity on a scale from 0 to 10 for the averaged ratings per participant and week.
Time frame: Daily for 2 weeks before treatment intake and 5 weeks during treatment intake
The Change of the Difference From Baseline and 5 Weeks of Treatment to the Respective Mean of CAR AUCg Measures
Efficacy of the intake of Lpc-37 on the reduction of the difference of Cortisol Awakening Response (CAR) area under the curve with respect to the ground (AUCg) values to the respective mean before and after 5 weeks of treatment. The CAR is summarized in the variables AUCg, AUCi, mean increase and peak value. These cortisol indices are frequently used to describe hypothalamic-pituitary-adrenal axis activity and represent information either of the total cortisol production or of the change in cortisol levels. AUCg is the total area under the curve of all measurements (i.e., the intensity or magnitude of the response). Efficacy for the CAR variables AUCg is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
Time frame: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake)
The Change of the Difference From Baseline and 5 Weeks of Treatment to the Respective Mean of Cortisol Awakening Response (CAR) AUCi Measures
Efficacy of the intake of Lpc-37 on the reduction of the difference of CAR area under the curve with respect to the increase (AUCi) values to the respective mean before and after the treatment. The CAR is summarized in the variables AUCg, AUCi, mean increase and peak value. These cortisol indices are frequently used to describe hypothalamic-pituitary-adrenal axis activity and represent information either of the total cortisol production or of the change in cortisol levels. AUCi is calculated with reference to the baseline measurement and it ignores the distance from zero for all measurements and emphasizes the changes over time. Efficacy for the CAR variables AUCi is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
Time frame: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake)
The Change of the Difference From Baseline and 5 Weeks of Treatment to the Respective Mean of Cortisol at Awakening Measures
Efficacy of the intake of Lpc-37 on the reduction of the difference of Cortisol at Awakening values to the respective mean before and after 5 weeks of treatment Efficacy for the CAR variable cortisol at awakening is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
Time frame: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake)
The Change of the Difference From Baseline and 5 Weeks of Treatment to the Respective Mean of CAR 8pm Measures
Efficacy of the intake of Lpc-37 on the reduction of the difference of cortisol at 8 pm values to the respective mean before and after 5 weeks of treatment Efficacy for the CAR variable cortisol at 8 pm is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
Time frame: Baseline (average of 2 days before first product intake) and end of study (average of 2 days before last product intake
| Milestone | Lpc-37 | Placebo |
|---|---|---|
| Started | 60 | 60 |
| Intervention (post 2 weeks run-in) | 59 | 59 |
| Completed | 59 | 58 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Antibiotic use | 1 | 0 |
Efficacy was defined as a lower increase in HR in response to the TSST following intervention with Lpc-37, compared to placebo.
| bpm | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -20min | 74.84 ± 10.20 | 74.34 ± 9.04 |
| Pre-TSST -10min | 88.15 ± 11.13 | 86.69 ± 10.74 |
| Pre-TSST -3min | 97.34 ± 17.15 | 97.62 ± 16.23 |
| during TSST (Interview) | 107.56 ± 21.56 | 105.66 ± 18.86 |
| during TSST (Arithmetic) | 102.77 ± 19.57 | 100.81 ± 17.20 |
| Post-TSST +10min | 93.32 ± 14.08 | 90.81 ± 12.11 |
| Post-TSST +20min | 75.88 ± 11.11 | 74.97 ± 9.86 |
Efficacy of the intake of Lpc-37 on the reduction of State-Trait-Anxiety-Inventory (STAI)-state scores compared to placebo. Measured with the german version of the State-Trait-Anxiety Inventory, scale anxiety as a temporary emotional state (STAI-X1). Answers are given on a four-point rating scale ranging from 1="not at all" to 4="very true". The score range is 20-80; Higher scores indicate more anxiety.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 33.65 ± 6.80 | 34.33 ± 7.73 |
| End of Study | 35.18 ± 8.38 | 35.33 ± 8.37 |
Efficacy of the intake of Lpc-37 on the reduction of Perceived Stress Scale (PSS) scores compared to placebo. Measured with the german version of the PSS as a psychological instrument for measuring stress perception. It assesses how unpredictable, uncontrollable and overloaded participants perceived their lives to have been within the last month. The PSS comprises 14 items that are answered on a five-point rating scale ranging from 0 = "never" to 4 = "very often". Individual scores on the PSS can range from 0 to 56 with higher scores indicating higher perceived stress.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 21.89 ± 7.90 | 20.72 ± 7.97 |
| End of Study | 20.49 ± 7.51 | 21.56 ± 8.16 |
Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) depression scores compared to placebo. Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content. Items are answered on a four point rating scale ranging from 0 = "not at all" to 3 = "very much". Scores of each scale are calculated by summing the scores for the relevant items. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The items are 3, 5, 10, 13, 16, 17, 21, 24, 26, 31, 34, 37, 38, 42 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 4.60 ± 4.94 | 5.21 ± 6.38 |
| End of Study | 4.15 ± 5.52 | 5.10 ± 5.61 |
Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) anxiety scores compared to placebo. Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content. Items are answered on a four point rating scale ranging from 0 = "not at all" to 3 = "very much". Scores of each scale are calculated by summing the scores for the relevant items. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The items are 2, 4, 7, 9, 15, 19, 20, 23, 25, 28, 30, 36, 40, 41 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 2.60 ± 3.35 | 3.07 ± 4.58 |
| End of Study | 2.44 ± 3.59 | 3.45 ± 5.08 |
Efficacy of the intake of Lpc-37 on the reduction of Depression Anxiety Stress Scale (DASS) stress scores compared to placebo. Measured with the german version of the DASS as a 42-item self report instrument designed to measure negative emotional states of depression, anxiety and stress during the past week. The DASS includes three scales (depression, anxiety and stress) of which each scale includes 14 items that are divided into subscales of 2-5 items of similar content. Items are answered on a four point rating scale ranging from 0 = "not at all" to 3 = "very much". Scores of each scale are calculated by summing the scores for the relevant items. The stress scale (items) is sensitive to levels of chronic non-specific arousal.The stress scale items are 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39 and individual scores can range from 0 to 42 with higher scores indicating greater severity of the symptoms.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 9.76 ± 7.92 | 9.41 ± 7.87 |
| End of Study | 8.91 ± 7.14 | 10.09 ± 8.17 |
Efficacy of the intake of Lpc-37 on the reduction of Beck Anxiety Inventory (BAI) scores compared to placebo. Measured with the german version of the Beck Anxiety Inventory as a self-rating scale designed to measure anxiety. It comprises 21 sentences describing feelings that can occur when being anxious. These sentences are rated on a four-point rating scale ranging from 0="not at all" to 3="severely", considering the last 7 days. The score range is 0-63; Higher scores indicate higher anxiety.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 5.51 ± 4.46 | 5.85 ± 5.73 |
| End of Study | 4.75 ± 4.39 | 6.33 ± 7.26 |
Efficacy of the intake of Lpc-37 on the reduction of Visual Analog Scale (VAS) stress perception scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating higher perceived stress.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 19.11 ± 22.97 | 19.34 ± 21.44 |
| End of Study | 23.32 ± 23.18 | 20.67 ± 21.63 |
Efficacy of the intake of Lpc-37 on the reduction of VAS anxiety scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater anxiety.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 7.29 ± 15.13 | 7.58 ± 14.05 |
| End of Study | 9.26 ± 16.48 | 7.85 ± 13.40 |
Efficacy of the intake of Lpc-37 on the reduction of VAS insecurity scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater insecurity.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 13.58 ± 21.41 | 15.91 ± 19.60 |
| End of Study | 16.44 ± 19.67 | 17.30 ± 20.15 |
Efficacy of the intake of Lpc-37 on the reduction of VAS exhaustion scores compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater exhaustion.
| score | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 29.56 ± 27.63 | 23.19 ± 21.08 |
| End of Study | 24.66 ± 22.78 | 18.45 ± 21.31 |
Efficacy of the intake of Lpc-37 on the reduction of systolic blood pressure (BP).
| mmHg | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 119.60 ± 14.21 | 119.66 ± 13.82 |
| End of Study | 121.87 ± 14.28 | 122.86 ± 14.14 |
Efficacy of the intake of Lpc-37 on the reduction of diastolic BP.
| mmHg | Lpc-37 | Placebo |
|---|---|---|
| Baseline | 71.89 ± 7.74 | 71.68 ± 9.16 |
| End of Study | 73.18 ± 7.45 | 74.62 ± 6.39 |
Efficacy of the intake of Lpc-37 on reduction of the increase of STAI-State scores in response to the TSST compared to placebo. Measured with the german version of the State-Trait-Anxiety Inventory, scale anxiety as a temporary emotional state (STAI-X1). Answers are given on a four-point rating scale ranging from 1="not at all" to 4="very true". The score range is 20-80; Higher scores indicate more anxiety.
| score | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -10min | 36.09 ± 8.45 | 36.83 ± 9.48 |
| Post-TSST +1min | 42.38 ± 10.91 | 43.60 ± 10.00 |
Efficacy of the intake of Lpc-37 on reduction of the increase of the systolic BP in response to the TSST compared to placebo.
| mmHg | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -3min | 115.11 ± 12.53 | 114.33 ± 14.07 |
| Post-TSST +1min | 127.47 ± 13.67 | 129.19 ± 14.33 |
Efficacy of the intake of Lpc-37 on reduction of the increase of the diastolic BP in response to the TSST compared to placebo.
| mmHg | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -3min | 79.13 ± 7.83 | 78.41 ± 8.32 |
| Post-TSST +1min | 90.38 ± 7.17 | 88.36 ± 9.72 |
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS Stress perception scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating higher perceived stress.
| score | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -10min | 19.89 ± 20.61 | 18.52 ± 21.73 |
| Interview TSST (during) | 47.71 ± 27.08 | 51.51 ± 28.10 |
| Post-TSST +1min | 31.72 ± 24.25 | 32.85 ± 23.66 |
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS anxiety scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater anxiety.
| score | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -10min | 6.80 ± 10.95 | 8.50 ± 14.94 |
| Interview TSST (during) | 20.85 ± 23.61 | 22.47 ± 23.51 |
| Post-TSST +1min | 10.68 ± 15.19 | 11.74 ± 18.46 |
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS insecurity scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater insecurity.
| score | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -10min | 14.47 ± 16.96 | 17.19 ± 21.37 |
| Interview TSST (during) | 45.08 ± 28.92 | 52.19 ± 27.16 |
| Post-TSST +1min | 23.92 ± 23.87 | 23.69 ± 23.58 |
Efficacy of the intake of Lpc-37 on reduction of the increase of VAS exhaustion scores in response to the TSST compared to placebo. Measured with a german version of the Visual Analog Scale (VAS) as a 10cm bipolar scale ranging from "not at all" to "highly". The participant indicated his/her actual perception by placing a mark on a line. VAS scores were obtained by using a ruler and measuring the position of the participants's mark with millimeter precision. To control for possible variations due to printing, the total length of the line was also measured and percentage scores for each participant were computed. Percentage scores range from 0-100. Higher scores indicating greater exhaustion.
| score | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -10min | 21.18 ± 21.49 | 19.79 ± 21.88 |
| Interview TSST (during) | 19.20 ± 21.11 | 21.30 ± 22.47 |
| Post-TSST +1min | 22.12 ± 22.46 | 25.68 ± 26.07 |
Efficacy of the intake of Lpc-37 on reduction of the increase of salivary cortisol in response to the TSST compared to placebo.
| nmol/L | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -2min | 4.79 ± 2.62 | 4.82 ± 2.60 |
| Post-TSST +1min | 6.96 ± 3.73 | 6.85 ± 3.50 |
| Post-TSST +10min | 9.48 ± 5.75 | 8.97 ± 5.84 |
| Post-TSST +20min | 9.89 ± 6.51 | 9.21 ± 6.59 |
| Post-TSST +30min | 8.04 ± 5.36 | 7.71 ± 5.06 |
| Post-TSST +45min | 6.21 ± 3.17 | 6.16 ± 3.79 |
Efficacy of the intake of Lpc-37 on reduction of the increase of salivary Alpha-Amylase (sAA) in response to the TSST compared to placebo.
| U/ml | Lpc-37 | Placebo |
|---|---|---|
| Pre-TSST -2min | 154.04 ± 98.17 | 161.67 ± 110.89 |
| Post-TSST +1min | 246.29 ± 153.62 | 270.55 ± 174.85 |
| Post-TSST +10min | 146.53 ± 86.80 | 158.85 ± 91.21 |
| Post-TSST +20min | 130.11 ± 82.45 | 141.49 ± 93.00 |
| Post-TSST +30min | 125.19 ± 79.67 | 138.48 ± 90.31 |
| Post-TSST +45min | 141.13 ± 92.94 | 148.15 ± 105.60 |
Efficacy of the intake of Lpc-37 on the increase of sleep duration over the course of the treatment. Sleep duration was monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Summary measures for Sleep duration for the averaged ratings per participant and week
| min | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 447.27 ± 47.50 | 447.45 ± 38.76 |
| Week 2 (run-in) | 444.01 ± 44.60 | 448.13 ± 41.62 |
| Week 3 (treatment) | 449.45 ± 41.47 | 456.90 ± 37.08 |
| Week 4 (treatment) | 450.62 ± 36.07 | 459.81 ± 39.44 |
| Week 5 (treatment) | 454.50 ± 39.82 | 457.26 ± 42.04 |
| Week 6 (treatment) | 450.88 ± 38.95 | 450.16 ± 42.04 |
| Week 7 (treatment) | 445.60 ± 40.02 | 459.66 ± 39.71 |
Efficacy of the intake of Lpc-37 on the increase of sleep related recovery scores over the course of the treatment. Measured with a daily online diary. Sleep related recovery was rated by participants on an 11-point scale (0-10; "not at all" to "very") and monitored throughout the wash-out phase (Week 1 and 2) and the subsequent treatment phase (weeks 3-7). High scores indicate a high recovery. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Summary measures for sleep related recovery for the averaged ratings per participant and week.
| score | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 6.71 ± 1.34 | 6.91 ± 1.00 |
| Week 2 (run-in) | 7.07 ± 1.28 | 7.15 ± 1.07 |
| Week 3 (treatment) | 7.32 ± 1.11 | 7.27 ± 1.12 |
| Week 4 (treatment) | 7.30 ± 1.30 | 7.29 ± 1.18 |
| Week 5 (treatment) | 7.36 ± 1.22 | 7.36 ± 1.19 |
| Week 6 (treatment) | 7.42 ± 1.19 | 7.10 ± 1.28 |
| Week 7 (treatment) | 7.31 ± 1.25 | 7.28 ± 1.18 |
Efficacy of the intake of Lpc-37 on the decrease of sleep disruptions over the course of the treatment measured with a daily online diary (Proportion (yes/total)). Sleep disruptions were monitored through the wash-out phase and the subsequent treatment phase for each week. In the binary version, the value is either Yes or No for each day and each participant. Efficacy is defined as a decrease, or (in case of a general increase) reduced increase for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. The proportion of participants with at least one sleep disruption by treatment group is given, treatment commenced after week 2. Data listed here reflect the proportion of participants who answered "Yes" (e.g. 0,477 \* 44 = 20.99 participants answered with "Yes" in week 1 in the Lpc-37 group).
| Proportion of participants (yes/total) | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 0.477 | 0.465 |
| Week 2 (run-in) | 0.435 | 0.426 |
| Week 3 (treatment) | 0.354 | 0.418 |
| Week 4 (treatment) | 0.367 | 0.310 |
| Week 5 (treatment) | 0.306 | 0.292 |
| Week 6 (treatment) | 0.279 | 0.331 |
| Week 7 (treatment) | 0.290 | 0.389 |
Efficacy of the intake of Lpc-37 on the decrease of reported number of sleep disruptions over the course of the treatment measured with a daily online diary (mean of week summary). Sleep disruptions were monitored through the wash-out phase (Week 1 and 2) and the subsequent treatment phase (Weeks 3-7). In the count version, the value can be 0 or a natural number for each day and each participant. Efficacy is defined as a decrease, or (in case of a general increase) reduced increase for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Values reflect summary measures for sleep disruptions (count) for the summed counts per participant and week.
| sleep disruptions per participant & week | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 7.30 ± 6.87 | 6.09 ± 4.96 |
| Week 2 (run-in) | 5.50 ± 4.62 | 5.49 ± 4.82 |
| Week 3 (treatment) | 4.89 ± 5.11 | 5.11 ± 4.89 |
| Week 4 (treatment) | 5.43 ± 9.20 | 4.30 ± 6.05 |
| Week 5 (treatment) | 3.52 ± 3.48 | 3.53 ± 3.80 |
| Week 6 (treatment) | 3.80 ± 7.40 | 4.02 ± 4.68 |
| Week 7 (treatment) | 4.66 ± 6.37 | 5.83 ± 6.23 |
Efficacy of the intake of Lpc-37 on the increase of perceived health status scores over the course of the treatment. Measured with a daily online diary. Health status was rated by participants on an 11-point scale (0-10; "not at all" to "very") and monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a high perceived health.Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one value for each day and participant. Values reflect summary measures for perceived health status on a scale from 0 to 10 for the averaged ratings per participant and week.
| score | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 7.80 ± 1.31 | 7.86 ± 1.08 |
| Week 2 (run-in) | 7.89 ± 1.15 | 7.92 ± 1.12 |
| Week 3 (treatment) | 7.88 ± 1.20 | 7.92 ± 1.06 |
| Week 4 (treatment) | 7.91 ± 1.18 | 8.01 ± 1.05 |
| Week 5 (treatment) | 8.05 ± 1.22 | 7.92 ± 1.16 |
| Week 6 (treatment) | 8.11 ± 1.20 | 7.73 ± 1.26 |
| Week 7 (treatment) | 7.91 ± 1.15 | 7.75 ± 1.52 |
Efficacy of the intake of Lpc-37 on the increase of mood scale scores over the course of the treatment Measured with a daily online diary. Mood was rated by participants on an 11-point scale (0-10; "very bad" to "very well") and monitored through the washout phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a better mood. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group. Time is coded as a continuous variable with one average value for each week and participant. Values reflect summary measures for mood ratings on a scale from 0 to 10 for the averaged ratings per participant and week.
| score | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 7.31 ± 1.25 | 7.27 ± 1.04 |
| Week 2 (run-in) | 7.53 ± 1.21 | 7.49 ± 1.10 |
| Week 3 (treatment) | 7.66 ± 1.05 | 7.46 ± 1.13 |
| Week 4 (treatment) | 7.77 ± 1.25 | 7.53 ± 1.15 |
| Week 5 (treatment) | 7.73 ± 1.17 | 7.50 ± 1.24 |
| Week 6 (treatment) | 7.90 ± 1.10 | 7.40 ± 1.21 |
| Week 7 (treatment) | 7.77 ± 1.30 | 7.55 ± 1.22 |
Efficacy of the intake of Lpc-37 on the increase of perceived productivity scores over the course of the treatment Measured with a daily online diary. Productivity was rated by participants on an 11-point scale (0-10; "not at all" to "very") and monitored through the wash-out phase (week 1 and 2) and the subsequent treatment phase (weeks 3-7). Higher scores indicate a higher perceived productivity. Efficacy is defined as an increase, or (in case of a general decrease) reduced decrease for the active treatment group as compared to the placebo group and operationalized as the interaction between time and treatment group.Time is coded as a continuous variable with one value for each day and participant. The values reflect summary measures for perceived productivity on a scale from 0 to 10 for the averaged ratings per participant and week.
| score | Lpc-37 | Placebo |
|---|---|---|
| Week 1 (run-in) | 6.98 ± 1.02 | 7.15 ± 1.07 |
| Week 2 (run-in) | 7.34 ± 1.06 | 7.29 ± 1.03 |
| Week 3 (treatment) | 7.53 ± 0.97 | 7.30 ± 1.01 |
| Week 4 (treatment) | 7.48 ± 1.19 | 7.34 ± 1.18 |
| Week 5 (treatment) | 7.59 ± 1.04 | 7.43 ± 1.17 |
| Week 6 (treatment) | 7.57 ± 1.13 | 7.31 ± 1.22 |
| Week 7 (treatment) | 7.50 ± 1.17 | 7.32 ± 1.25 |
Efficacy of the intake of Lpc-37 on the reduction of the difference of Cortisol Awakening Response (CAR) area under the curve with respect to the ground (AUCg) values to the respective mean before and after 5 weeks of treatment. The CAR is summarized in the variables AUCg, AUCi, mean increase and peak value. These cortisol indices are frequently used to describe hypothalamic-pituitary-adrenal axis activity and represent information either of the total cortisol production or of the change in cortisol levels. AUCg is the total area under the curve of all measurements (i.e., the intensity or magnitude of the response). Efficacy for the CAR variables AUCg is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
| number of participants | Lpc-37 | Placebo |
|---|---|---|
| Baseline (<25% quantile) | 6 | 12 |
| Baseline (25% - 75% quantile) | 36 | 30 |
| Baseline (>75% quantile) | 11 | 13 |
| End of Study (<25% quantile) | 11 | 7 |
| End of Study (25% - 75% quantile) | 28 | 35 |
| End of Study (>75% quantile) | 14 | 13 |
Efficacy of the intake of Lpc-37 on the reduction of the difference of CAR area under the curve with respect to the increase (AUCi) values to the respective mean before and after the treatment. The CAR is summarized in the variables AUCg, AUCi, mean increase and peak value. These cortisol indices are frequently used to describe hypothalamic-pituitary-adrenal axis activity and represent information either of the total cortisol production or of the change in cortisol levels. AUCi is calculated with reference to the baseline measurement and it ignores the distance from zero for all measurements and emphasizes the changes over time. Efficacy for the CAR variables AUCi is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
| number of participants | Lpc-37 | Placebo |
|---|---|---|
| Baseline (<25% quantile) | 16 | 22 |
| Baseline (25% - 75% quantile) | 34 | 28 |
| Baseline (>75% quantile) | 3 | 5 |
| End of Study (<25% quantile) | 15 | 15 |
| End of Study (25% - 75% quantile) | 34 | 36 |
| End of Study (>75% quantile) | 4 | 4 |
Efficacy of the intake of Lpc-37 on the reduction of the difference of Cortisol at Awakening values to the respective mean before and after 5 weeks of treatment Efficacy for the CAR variable cortisol at awakening is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
| number of participants | Lpc-37 | Placebo |
|---|---|---|
| Baseline (<25% quantile) | 14 | 16 |
| Baseline (25% - 75% quantile) | 31 | 26 |
| Baseline (>75% quantile) | 8 | 13 |
| End of Study (<25% quantile) | 19 | 12 |
| End of Study (25% - 75% quantile) | 26 | 34 |
| End of Study (>75% quantile) | 8 | 9 |
Efficacy of the intake of Lpc-37 on the reduction of the difference of cortisol at 8 pm values to the respective mean before and after 5 weeks of treatment Efficacy for the CAR variable cortisol at 8 pm is defined in terms of a normalization: Number of participants with normal values (between first and third quantile of reference measures) and numbers of participants with low or high values are compared before treatment and after treatment. More participants in the normal range after treatment is defined as efficacy.
| number of participants | Lpc-37 | Placebo |
|---|---|---|
| Baseline (<25% quantile) | 4 | 6 |
| Baseline (25% - 75% quantile) | 20 | 23 |
| Baseline (>75% quantile) | 29 | 26 |
| End of Study (<25% quantile) | 3 | 7 |
| End of Study (25% - 75% quantile) | 28 | 18 |
| End of Study (>75% quantile) | 22 | 30 |
Collected over Adverse event (AE) data was collected daily during the 5-week intervention period and tracked when the AE continued at the end of the study (up to 30 days afterwards). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lpc-37 | 0/59 (0%) | 0/59 (0%) | 29/59 (49.2%) |
| Placebo | 0/59 (0%) | 0/59 (0%) | 26/59 (44.1%) |
| Event | Lpc-37 | Placebo |
|---|---|---|
| headacheNervous system disorders | 22/59 | 15/59 |
| sore throatRespiratory, thoracic and mediastinal disorders | 6/59 | 8/59 |
| stomach acheGastrointestinal disorders | 5/59 | 7/59 |
| common coldRespiratory, thoracic and mediastinal disorders | 5/59 | 4/59 |
| Head coldInfections and infestations | 2/59 | 4/59 |
| VertigoCardiac disorders | 2/59 | 4/59 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/59 | 3/59 |
| Discomfort/Complaints related to the menstrual cycleGeneral disorders | 2/59 | 3/59 |
120 participants met the inclusion/exlusion criteria and were enrolled in the study. Two participants were excluded during the run-in period (use of antibiotics and withdrawn consent) and one participant withdrew consent during the intervention period.
| Age, Continuous(years) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Mean | 23.73 ± 4.27 | 23.25 ± 4.20 | 23.49 ± 4.22 |
| Sex: Female, Male(Participants) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Female | 30 | 30 | 60 |
| Male | 30 | 30 | 60 |
| Race and Ethnicity Not Collected(Participants) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Germany | 60 | 60 | 120 |
| Weight(kg) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Mean | 71.13 ± 11.05 | 69.79 ± 12.15 | 70.46 ± 11.58 |
| Height(cm) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Mean | 175.58 ± 8.86 | 173.58 ± 9.33 | 174.58 ± 9.11 |
| Body Mass Index (BMI)(kg/m²) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Mean | 22.97 ± 2.30 | 23.02 ± 2.67 | 23.00 ± 2.48 |
| Systolic blood pressure (BP)(mmHg) | Lpc-37 | Placebo | Total |
|---|---|---|---|
| Mean | 120.75 ± 12.09 | 120.72 ± 13.47 | 120.73 ± 12.74 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Oct 2018, 5 months.
Results were first posted in Feb 2021, 2 years 4 months after primary completion.
Of 459 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 5 months is below that.
Counting every sponsor, half of 472 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Daacro