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

NCT07387991 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Lindenwood University

    lead OTHER

Principal Investigators

  • Chad M Kerksick, PhD · Lindenwood University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387991 on ClinicalTrials.gov