Who is eligible for clinical trial NCT06795425?

Participants must meet protocol criteria for Oxidative Stress. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06795425 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-01-21

A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance (NCT06795425)

🟡 Not Yet Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Lindenwood University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (16 items).

Location: Exercise and Performance Nutrition Laboratory — Saint Charles, Missouri

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

EXCLUSION CRITERIA 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Exercise and Performance Nutrition Laboratory — Saint Charles, Missouri

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗