Not Yet RecruitingNot Applicable

Evaluating the Ability of a Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability

United States50 participantsStarted 2026-06-01

Plain-language summary

This study will evaluate the effects of a multi-strain postbiotic supplement on markers of inflammation, immune function, gastrointestinal symptoms, psychological well-being, and intestinal permeability in healthy adults. The primary objective is to determine whether four weeks of postbiotic supplementation alters physiological and perceptual responses to a standardized bout of moderate-to-high intensity exercise compared with placebo. Approximately 50 healthy men and women aged 18 to 55 years will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 days. At the end of the supplementation period, participants will complete a 45-minute treadmill exercise bout at 75% of their individually determined maximum heart rate. Blood samples will be collected to assess biomarkers of inflammation, immune activity, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be evaluated using validated questionnaires. This study is designed to determine whether postbiotic supplementation modulates physiological stress responses and subjective well-being following prolonged exercise in healthy adults.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion Criteria: Healthy males and females aged 18 to 55 years of age. Individual indicates they are physically active defined as: 30 minutes of moderate intensity activity 4 days per week in the past 3 months. Subject has the ability to exercise on a treadmill without issue or concern. Body Mass Index (BMI) 18.0-32.0 kg/m2 (normal weight to obesity weight). The average BMI of the entire cohort will be \<30.0 kg/m2. Subject is in good health and appropriate for exercise as determined by physical examination and medical history. Subject can exercise on a treadmill without issue or concern. Subject is a non-smoker. Subject agrees to not use any new vitamin, mineral, or dietary supplements 24 hours prior to the exercise test visits. Subject is willing and able to comply with the protocol including: attending the study scheduled appointments, of which two of the study visits may take up to four hours of completion. Subject agrees to refrain from exercise for the 24 hours prior to any test visits. Subject agrees to refrain from alcohol use for at least 24 hours before every study visit. Subject is able to understand and sign the informed consent to participate in the study. Exclusion Criteria: Individuals who are determined to have liver, renal, cardiovascular, or other metabolic disease. Use of any dietary supplements, prescription mediation (particularly antibiotics and/or anti-inflammatories), or probiotics within the past 2 months which may confound the study or …

What they're measuring

Interleukin-6 (IL-6)

Timeframe: Serum IL-6 concentrations will be measured using multiplex bead-based assays to assess the inflammatory response to a standardized 45-minute treadmill exercise bout following 28 days of supplementation.

Tumor Necrosis Factor-α (TNF-α)

Timeframe: Serum TNF-α concentrations will be measured using multiplex bead-based assays to assess exercise-induced inflammatory responses following supplementation.

Interleukin-10 (IL-10)

Timeframe: Serum IL-10 concentrations will be measured to assess anti-inflammatory and immune regulatory responses to exercise following supplementation.

Perceived Recovery Scale (PRS)

Timeframe: Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise

Trial details

NCT IDNCT07387991

SponsorLindenwood University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Anthony M Hagele, MS

6369494785 ahagele@lindenwood.edu

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