An interventional study of Postbiotic Active Lifestyle Blend and Placebo in Oxidative Stress, Healthy and Exercise-induced Muscle Damage, sponsored by Lindenwood University. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Lindenwood University · Not applicable, Interventional, and Treatment
This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.
This randomized, double-blind, placebo-controlled study will evaluate the effect of a novel postbiotic blend on oxidative stress markers and exercise performance in healthy, physically active adults. The study aims to determine whether the postbiotic supplement can reduce oxidative stress and enhance exercise outcomes over an 8-week period.
Participants will be randomly assigned to receive either the postbiotic blend or a placebo in a double-blind fashion. The study includes an 8-week intervention period, with baseline and follow-up assessments conducted to evaluate changes in key biomarkers and performance metrics.
The primary outcome measure will focus on changes in malondialdehyde concentrations, a key marker of oxidative stress. Secondary outcomes will include assessments of other oxidative stress markers, immune function, and exercise performance. Detailed descriptions of these outcome measures are provided in the "Outcome Measures" section.
Participants will undergo a series of assessments at baseline, mid-study, and post-intervention. These assessments include blood draws, VO2 peak testing, and exercise performance tests. Participants will also be required to maintain a daily diary documenting their health status, medication/supplement use, and any adverse events.
The total study duration is 8-10 weeks, including a pre-study screening phase, 8 weeks of intervention, and a follow-up assessment.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 64 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Lindenwood University is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
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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.
To be eligible for inclusion, the participant must fulfill all of the following criteria:
EXCLUSION CRITERIA
Participants will be excluded from the study if they meet any of the following 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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Participants in this arm will receive the active Postbiotic Active Lifestyle Blend supplement, which contains a heat-treated blend of bacterial strains
Dietary Supplement: Postbiotic Active Lifestyle Blend
Participants in this arm will receive a placebo capsule that matches the appearance and dosage of the active blend.
Other: Placebo
The active intervention, Postbiotic Active Lifestyle Blend, containing a heat-treated blend of bacterial strains; 2 capsules per day.
The placebo intervention contains no active ingredients and consists of maltodextrin as an inactive ingredient. The capsule matches the appearance and dosage form of the active intervention.
Change from Baseline in Serum Malondialdehyde Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion After 0 and 8 Weeks of Supplementation
Serum malondialdehyde (MDA) concentration will be measured to assess the effect of the postbiotic blend on lipid peroxidation and oxidative stress. Higher MDA levels indicate increased oxidative stress.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Urine 8-OHdG During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation
Urinary 8-OHdG, a biomarker for oxidative DNA damage, will be measured to evaluate oxidative stress. Values reflect the total oxidative stress experienced by participants.
Time frame: 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Oxidized LDL Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Serum oxidized LDL will be measured as an indicator of oxidative modification in lipids, associated with cardiovascular risk. Higher levels represent increased lipid oxidation.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Glutathione Peroxidase Activity 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Glutathione peroxidase levels, a measure of antioxidant enzyme activity, will be assessed in serum. Higher activity indicates greater antioxidant defense.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Urinary 8-Isoprostane Levels During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation
Urinary 8-isoprostane, a marker for lipid peroxidation, will be measured to assess oxidative stress. Higher values indicate greater oxidative damage to lipids.
Time frame: 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Total Antioxidant Status (TAS) 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Total Antioxidant Status (TAS) in serum will be measured to gauge overall antioxidant capacity. Higher levels indicate a stronger antioxidant defense.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Superoxide Dismutase Activity 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Serum superoxide dismutase (SOD) activity, an antioxidant enzyme, will be measured to assess the body's defense against superoxide radicals. Higher activity levels indicate greater antioxidative defense.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Protein Carbonyl Levels 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Serum protein carbonyls, markers of oxidative damage to proteins, will be measured. Higher levels indicate increased protein oxidation and cellular stress.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Uric Acid Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
Serum uric acid will be measured as an indicator of purine metabolism and antioxidant activity, where higher levels may indicate greater antioxidant activity or metabolic changes.
Time frame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum IgA Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
Immunoglobulin A (IgA) levels in serum will be measured to assess immune function, with higher levels indicating a robust immune response
Time frame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum IgM Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
Immunoglobulin M (IgM) levels in serum will be measured to assess immune function, with higher levels indicating a robust immune response
Time frame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum IgG Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
Immunoglobulin G (IgG) levels in serum will be measured to assess immune function, with higher levels indicating a robust immune response
Time frame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
Change from Baseline in Serum Creatine Kinase Levels 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Serum creatine kinase (CK), a marker of muscle damage, will be measured. Higher CK levels indicate greater muscle stress or damage.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Perceived Soreness (DOMS) Using Visual Analog Scale (VAS) at 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Delayed onset muscle soreness (DOMS) will be self-rated using a 10-point visual analog scale (VAS), where 0 indicates no soreness and 10 represents extreme soreness.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Perceived Recovery Using Visual Analog Scale (VAS) at 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Recovery will be self-rated by participants on a 10-point VAS, where 0 represents no recovery and 10 represents full recovery.
Time frame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
Change from Baseline in Perceived Soreness (DOMS) of Quadriceps Using a Digital Algometer 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
Perceived muscle soreness in the quadriceps will be assessed using a digital algometer, which applies consistent pressure to measure pain threshold and discomfort. Higher readings indicate higher resistance to soreness, while lower values indicate increased perceived soreness.
Time frame: Approximately 30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
Daily Self-Report Diary on Upper Respiratory Tract and Gastrointestinal Symptoms Over 8 Weeks of Supplementation
Participants will complete a daily diary to self-report any symptoms related to upper respiratory tract infections (URTI) and gastrointestinal (GI) health throughout the 8-week supplementation period. This diary will track symptom type, severity, and duration.
Time frame: Daily throughout the 8-week supplementation period.
Change from Baseline in Gastrointestinal Symptoms Using the Gastrointestinal Symptom Rating Scale (GSRS) Before and After 8 Weeks of Supplementation
The Gastrointestinal Symptoms Rating Scale (GSRS) will assess GI symptoms across multiple dimensions, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Scores range from 1 (no discomfort) to 7 (severe discomfort) on each dimension, with higher scores indicating greater symptom severity.
Time frame: Baseline (pre-supplementation) and after 8 weeks of supplementation.
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score Before and After 8 Weeks of Supplementation
The GAD-7, a 7-item self-report questionnaire, will assess anxiety levels. Scores range from 0 to 21, with higher scores indicating greater anxiety severity. The questionnaire will be completed by participants before and after supplementation.
Time frame: Baseline (pre-supplementation) and after 8 weeks of supplementation
Change from Baseline in Perceived Restfulness Using Visual Analog Scale (VAS) After 0 and 8 Weeks of Supplementation
Perceived restfulness will be assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no restfulness and 10 represents feeling fully rested. Participants will complete the scale at baseline and at the end of the supplementation period.
Time frame: After 0 and 8 weeks of supplementation.
Change from Baseline in Perceived Sleep Quality Using Visual Analog Scale (VAS) After 0 and 8 Weeks of Supplementation
Perceived sleep quality will be rated on a 10-point Visual Analog Scale (VAS), with 0 indicating poor sleep quality and 10 indicating excellent sleep quality. Participants will complete the scale at baseline and after the supplementation period.
Time frame: After 0 and 8 weeks of supplementation.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score Before and After 8 Weeks of Supplementation
The Pittsburgh Sleep Quality Index (PSQI), a self-rated questionnaire, assesses overall sleep quality and disturbances over a 1-month period. Scores range from 0 to 21, with higher scores indicating worse sleep quality. The PSQI will be completed at baseline and after the supplementation period.
Time frame: Baseline (pre-supplementation) and after 8 weeks of supplementation.
Change from Baseline in Running Distance (Miles) Covered During 10-Minute Time Trial After 0 and 8 Weeks of Supplementation
The total distance in miles covered during a 10-minute running time trial will be measured to assess exercise performance. Greater distance covered indicates improved aerobic capacity and endurance.
Time frame: After 0 weeks (baseline) and after 8 weeks of supplementation.
Change from Baseline in Heart Rate (bpm) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation
Heart rate, measured in beats per minute (bpm), will be assessed throughout treadmill running to monitor cardiovascular response. Lower heart rates at a set intensity indicate improved cardiovascular efficiency.
Time frame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Rating of Perceived Exertion (RPE) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation
RPE will be recorded using the Borg scale (6-20), where higher values indicate greater perceived effort. Lower RPE values at a fixed intensity suggest improved endurance and perceived ease of exercise.
Time frame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Blood Lactate Levels (mmol/L) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation
Blood lactate, measured in mmol/L, will be assessed as a marker of metabolic stress, with lower levels indicating improved lactate clearance and aerobic efficiency.
Time frame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Blood Glucose Levels (mg/dL) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation
Blood glucose, measured in mg/dL, will be monitored to assess energy utilization. Stable or lower levels may indicate improved metabolic flexibility.
Time frame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Fat Oxidation Rate (g/min) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation
Fat oxidation rate, measured in grams per minute (g/min), will be assessed to evaluate substrate utilization, with higher rates suggesting greater reliance on fat as an energy source.
Time frame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Carbohydrate Oxidation Rate (g/min) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation
Carbohydrate oxidation rate, measured in grams per minute (g/min), will be assessed to evaluate energy source utilization, with lower rates indicating improved fat utilization at moderate intensities.
Time frame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
Daily Self-Reported Adverse Event (AE) Log Throughout 8-Week Supplementation Period
Participants will complete a daily self-report diary to record any adverse events (AEs) experienced, detailing the type, severity, duration, and any related symptoms. This log will help monitor the safety and tolerability of the supplementation over the study period.
Time frame: Daily throughout the 8-week supplementation period.
Change from Baseline in Gut Microbiome Composition Using Shotgun Metagenomic Sequencing (Fecal) During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation
Shotgun metagenomic sequencing will analyze the composition and diversity of the gut microbiome in fecal samples. This measure provides insights into microbiome changes related to supplementation and exercise, with results expressed as relative abundance and diversity of microbial species.
Time frame: 24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
Change from Baseline in Fecal Metabolomic Profile During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation
Fecal metabolomic analysis will assess the profile of metabolites produced by the gut microbiota, providing insights into metabolic changes. Metabolite concentrations will be reported, with changes potentially reflecting shifts in gut microbial activity and metabolic byproducts.
Time frame: 24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
Plan to share: No — There is no plan to make IPD available.
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Ran from Jan 2025 to primary completion in Sep 2026, 20 months.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 20 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: start Feb 2025 → Jan 2025, primary completion Jan 2026 → Sep 2026 and completion Jan 2026 → Sep 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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