An interventional study of Experimental probiotic product and Placebo comparator in Mild to Moderate Levels of Stress, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Other
This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.
The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.
The objectives is three:
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks
Dietary Supplement: Experimental probiotic product
Sachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks
Other: Placebo comparator
Probiotic supplementation
Placebo
Salivary cortisol level
Salivary cortisol levels (nmol/L) before and after stressor
Time frame: Before the stressor (time-point -20 minutes) and after the stressor (time-point +0 min, time-point +5 min, time-point +10 min, time-point +20 min, time-point +30 min, time-point +40 min) at both baseline and after 6 weeks of treatment
Cortisol level from waking saliva samples
Cortisol level (nmol/L) from waking saliva samples collected 0, 15, 30, 45, 60 min after waking
Time frame: Baseline and after 6 weeks treatment
Mean heart rate variability
Mean heart rate variability in the time (ms) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
Time frame: Baseline and after 6 weeks treatment
Heart frequency
Heart frequency (Hz) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
Time frame: Baseline and after 6 weeks treatment
Mean skin conductance level
Mean skin conductance level (SCL, kΩ) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
Time frame: Baseline and after 6 weeks treatment
Self-reported measures before and after the stressor (PANAS)
Positive and negative affect scores (1-50) computed with the Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline and after 6 weeks treatment
Self-reported measures before and after the stressor (STAI-6)
Likert scores (1-4) for 6 mood dimensions: calm, tense, upset, relaxed, content, worry from the State Trait Anxiety Inventory 6-item short form (STAI-6)
Time frame: Baseline and after 6 weeks treatment
Self-reported measures before, during and after the stressor (VAS)
VAS scores in mm (0-100) for subjective perception of the stress induction
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (PSS)
Perceived stress score (0-56) computed from the Perceived Stress Scale (PSS)
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (HADs)
Scores (0-21) of depression and anxiety computed from the Hospital Anxiety and Depression scale (HADs)
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (GSRS)
Scores from the Gastrointestinal Symptom-Rating Scale (GSRS): scores range from 1 to 7 and higher scores represent more discomfort
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)
Sleep quality score from the Pittsburgh Sleep Quality Index questionnaire (score 0-21: the lower, the better sleep quality)
Time frame: Baseline and after 6 weeks treatment
Probiotic in feces
Probiotic quantity in feces (genome copy number / million 16S copy number)
Time frame: Baseline and after 6 weeks treatment
Microbiome related metabolites in stool, blood and urine
Microbiome related metabolites in stool, blood and urine
Time frame: Baseline and after 6 weeks treatment
Plan to share: No — No plan
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Société des Produits Nestlé (SPN)