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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-24-16 | Other Identifier | Lindenwood University Institutional Review Board |
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| Name | Class |
|---|---|
| Archer Daniels Midland Co. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postbiotic Active Lifestyle Blend | Experimental | Participants in this arm will receive the active Postbiotic Active Lifestyle Blend supplement, which contains a heat-treated blend of bacterial strains |
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| Placebo | Placebo Comparator | Participants in this arm will receive a placebo capsule that matches the appearance and dosage of the active blend. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postbiotic Active Lifestyle Blend | Dietary Supplement | The active intervention, Postbiotic Active Lifestyle Blend, containing a heat-treated blend of bacterial strains; 2 capsules per day. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
INCLUSION CRITERIA
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony M Hagele, MS | Contact | 636-949-4785 | ahagele@lindenwood.edu | |
| Joesi M Krieger, MS | Contact | 636-339-6942 | jmorey@lindenwood.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chad M Kerksick, PhD | Lindenwood University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise and Performance Nutrition Laboratory | Saint Charles | Missouri | 63301 | United States |
There is no plan to make IPD available.
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This study uses a randomized, double-blind, parallel design with two groups. Participants are assigned to either the active postbiotic blend group or a placebo group to evaluate the blend's effects on oxidative stress, muscle recovery, immune function, and exercise performance.
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To maintain blinding, each participant is assigned a unique randomization number, rather than a direct treatment label (e.g., "A" or "B"). Treatments are provided with coded labels, ensuring that participants, investigators, outcome assessors, and any other study staff involved in data collection remain unaware of the group assignments throughout the study.
| Placebo | Other | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Daily throughout the 8-week supplementation period. |
| 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. | 24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation. |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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