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NCT07387991

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

Sponsor: Lindenwood University

View on ClinicalTrials.gov

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.

Official title: Clinical Trial to Evaluate the Ability of Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2027-06-01

Last Updated

2026-02-04

Healthy Volunteers

Yes

Conditions

Inflammation Gastrointestinal Symptoms

Interventions

DIETARY_SUPPLEMENT

Multi-Strain Postbiotic

Participants will ingest a multi-strain postbiotic supplement once daily for 28 days. Each dose will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening.

DIETARY_SUPPLEMENT

Placebo

Participants will ingest a placebo consisting of microcrystalline cellulose in capsule form once daily for 28 days. The placebo capsules will be identical in size, color, and appearance to the active supplement and will be consumed with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening.

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 its endpoints. Alcohol consumption (\>2 standard alcoholic drinks/day or \>10 drinks/week) or drug abuse/dependence. Smokers (defined as greater than 2 cigarettes per day for past 90 days). Clinically significant abnormal laboratory results at screening. Allergy or sensitivity to study supplement ingredients. Individuals who are cognitively impaired and/or who are unable to give informed consent. Individuals with diabetes, asthma, rheumatoid arthritis, colitis, IBS/IBD, gout, or fibromyalgia. Any other condition which in the PI's opinion may adversely affect the subject's ability to complete the study, its measurement or poses significant risk to the subject.

Locations (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, United States