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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Oxidative Stress, Healthy, Exercise-induced Muscle Damage, Exercise-induced Muscle Soreness, Immune Function, Gut Health, Microbiome Analysis, Exercise Performance, Exercise Metabolism

In brief

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.

Key facts

Study ID: NCT06795425
Run by: Lindenwood University
People needed: 80
Starts: 2025-02-01
Expected to finish: 2026-01-01
Last updated by the study team: 2025-01-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

To be eligible for inclusion, the participant must fulfill all of the following criteria:
Male or female participants between 18 - 45 years of age
Signed informed consent.
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.
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)
Body mass index values will range from >18.5 to < 29.9 kg/m2 (Inclusive)41 (Weir and Jan 2024).
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.

You may not qualify if…

Participants will be excluded from the study if they meet any of the following criteria:
Body mass index <18.5 to <29.9 kg/m2 (Inclusive)
Use of antibiotics or probiotics in the previous 3 months
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.
Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
Diagnosed with major affective disorder or other significant psychiatric disorder or disturbance that required hospitalization or home intervention in the prior year.
History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
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)
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.
Consumption (any dose or amount) of any nicotine-containing product (cigarette, cigar, vaping, etc.)
Participants who are lactating, pregnant or planning to become pregnant.
History of alcohol or substance abuse in the 12 months prior to screening
Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol.
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.
Extensive travel (>1 month) that will disrupt original outline of the study protocol.
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.

Where it is running

Exercise and Performance Nutrition Laboratory — Saint Charles, Missouri, United States

Full record on ClinicalTrials.gov

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