NCT06795425

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Lindenwood University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oxidative Stress
• Healthy
• Exercise-induced Muscle Damage
• Exercise-induced Muscle Soreness
• Immune Function
• Gut Health
• Microbiome Analysis
• Exercise Performance
• Exercise Metabolism

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Postbiotic Active Lifestyle Blend	The active intervention, Postbiotic Active Lifestyle Blend, containing a heat-treated blend of bacterial strains; 2 capsules per day.
OTHER	Placebo	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States