A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance

N/ANot Yet RecruitingNCT06795425

Lindenwood University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts