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

NCT07387991 | Not Yet Recruiting

• 1 other identifier: IRB-26-17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Inflammation; Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (4)

• Interleukin-6 (IL-6)

  Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation

  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)

  Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation

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

• Interleukin-10 (IL-10)

  Baseline, pre-exercise, immediately post-exercise, 1-hour post-exercise, 3-hours post-exercise, and 24-hours post-exercise after 28 days of supplementation

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

• Perceived Recovery Scale (PRS)

  Subjective recovery will be assessed using the Perceived Recovery Scale (PRS), a 0-10 scale reflecting perceived readiness and recovery status.

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

Study Arms (2)

Postbiotic

EXPERIMENTAL

Participants assigned to the postbiotic group will consume a multi-strain postbiotic supplement daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water.

Dietary Supplement: Multi-Strain Postbiotic

Placebo

PLACEBO COMPARATOR

Participants assigned to the placebo group will consume a placebo consisting of microcrystalline cellulose in capsule form daily for 28 consecutive days prior to completing a standardized treadmill exercise bout. The placebo capsules will be identical in size, color, and appearance to the postbiotic capsules and will be consumed once daily with approximately eight ounces of water.

Dietary Supplement: Placebo

Interventions

Multi-Strain Postbiotic DIETARY_SUPPLEMENT

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.

Postbiotic

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony M Hagele, MS

CONTACT

6369494785; ahagele@lindenwood.edu

Joesi M Krieger, MS

CONTACT

6369494785; jmorey@lindenwood.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a randomized, double-blind, placebo-controlled, parallel-group design. Eligible participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 consecutive days. Randomization will be stratified by sex and age. Participants will remain in their assigned intervention group for the duration of the study. At the end of the supplementation period, all participants will complete a standardized 45-minute treadmill exercise bout at 72 to 78% of predicted maximum heart rate to induce a controlled physiological stress. Biological, gastrointestinal, and psychological responses will be assessed before and after the exercise bout to compare responses between the postbiotic and placebo groups.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)