Clinical trial NCT06795425: A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study, to Assess the Effect of a Novel Postbiotic Blend on Exercise Induced Oxidative Stress Markers and Exercise Performance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oxidative Stress
Healthy
Exercise-induced Muscle Damage
Exercise-induced Muscle Soreness
Immune Function
Gut Health
Microbiome Analysis
Exercise Performance
Exercise Metabolism
Keywords: oxidative stress
antioxidants
postbiotics
ergogenic aid
exercise performance
muscle damage
recovery
gut microbiome
immune function
sleep quality
anxiety
recreationally active
inflammation
endurance training
fecal microbiota
nutritional supplement
aerobic exercise
biomarkers
clinical trial
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: Archer Daniels Midland Co.
First posted: 2025-01-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: INCLUSION CRITERIA

To be eligible for inclusion, the participant must fulfill all of the following criteria:

1. Male or female participants between 18 - 45 years of age
2. Signed informed consent.
3. Health, which is defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With research team and principal investigator discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase risk of study participation and the treatment or illness itself will not confound with desired study outcomes.
4. Physically active, which is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week at a rating of perceived intensity (RPE) of 4 or greater (out of 10)
5. Body mass index values will range from \>18.5 to \< 29.9 kg/m2 (Inclusive)41 (Weir and Jan 2024).
6. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures.

EXCLUSION CRITERIA

Participants will be excluded from the study if they meet any of the following criteria:

1. Body mass index \<18.5 to \<29.9 kg/m2 (Inclusive)
2. Use of antibiotics or probiotics in the previous 3 months
3. Positive medical history and/or is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease or other diagnosed hepatic impairment.
4. Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose \> 126 mg/dL)
5. Diagnosed with major affective disorder or other significant psychiatric disorder or disturbance that required hospitalization or home intervention in the prior year.
6. History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
7. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, bile acid malabsorption, H.pylori infection, small intestine bacterial overgrowth (SIBO), celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
8. Recently prescribed or change in dosage (within the past 6 months) of statin drug (i.e., Lipitor, Livalo, Crestor, Zocor, etc.), hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.), or psychiatric medications.
9. Consumption (any dose or amount) of any nicotine-containing product (cigarette, cigar, vaping, etc.)
10. Participants who are lactating, pregnant or planning to become pregnant.
11. History of alcohol or substance abuse in the 12 months prior to screening
12. Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol.
13. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
14. Extensive travel (\>1 month) that will disrupt original outline of the study protocol.
15. Participant is consuming a biotic product (pre-, pro-, syn-, or post-) or alters their diet resulting in a change in the amount of prebiotic, probiotic, or fermented foods that are consumed while in the study protocol.

Primary outcomes:
measure: Change from Baseline in Serum Malondialdehyde Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion After 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
Secondary outcomes:
measure: 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
timeFrame: 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum Oxidized LDL Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum Glutathione Peroxidase Activity 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: 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
timeFrame: 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.
measure: 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
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum Superoxide Dismutase Activity 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum Protein Carbonyl Levels 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum Uric Acid Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum IgA Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum IgM Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum IgG Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before exercise at baseline and after 8 weeks of supplementation.
measure: Change from Baseline in Serum Creatine Kinase Levels 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: 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
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: 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
timeFrame: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.
measure: 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
timeFrame: Approximately 30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
measure: Daily Self-Report Diary on Upper Respiratory Tract and Gastrointestinal Symptoms Over 8 Weeks of Supplementation
timeFrame: Daily throughout the 8-week supplementation period.
measure: Change from Baseline in Gastrointestinal Symptoms Using the Gastrointestinal Symptom Rating Scale (GSRS) Before and After 8 Weeks of Supplementation
timeFrame: Baseline (pre-supplementation) and after 8 weeks of supplementation.
measure: Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score Before and After 8 Weeks of Supplementation
timeFrame: Baseline (pre-supplementation) and after 8 weeks of supplementation
measure: Change from Baseline in Perceived Restfulness Using Visual Analog Scale (VAS) After 0 and 8 Weeks of Supplementation
timeFrame: After 0 and 8 weeks of supplementation.
measure: Change from Baseline in Perceived Sleep Quality Using Visual Analog Scale (VAS) After 0 and 8 Weeks of Supplementation
timeFrame: After 0 and 8 weeks of supplementation.
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score Before and After 8 Weeks of Supplementation
timeFrame: Baseline (pre-supplementation) and after 8 weeks of supplementation.
measure: Change from Baseline in Running Distance (Miles) Covered During 10-Minute Time Trial After 0 and 8 Weeks of Supplementation
timeFrame: After 0 weeks (baseline) and after 8 weeks of supplementation.
measure: 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
timeFrame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
measure: 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
timeFrame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
measure: 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
timeFrame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
measure: 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
timeFrame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
measure: 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
timeFrame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
measure: 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
timeFrame: 0, 15, 30, and 45 minutes during treadmill running at baseline (0 weeks) and after 8 weeks of supplementation.
measure: Daily Self-Reported Adverse Event (AE) Log Throughout 8-Week Supplementation Period
timeFrame: Daily throughout the 8-week supplementation period.
Other outcomes:
measure: 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
timeFrame: 24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
measure: 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
timeFrame: 24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.
Locations:
city: Saint Charles
country: United States
facility: Exercise and Performance Nutrition Laboratory
state: Missouri
Study officials:
affiliation: Lindenwood University
name: Chad M Kerksick, PhD
role: PRINCIPAL_INVESTIGATOR
References: