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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Gastrointestinal Symptoms
• Intervention / Treatment: Dietary supplement: Multi-Strain Postbiotic; Dietary supplement: Placebo

Detailed Description

This study is designed to evaluate the effects of a multi-strain postbiotic supplement on physiological, gastrointestinal, and psychological responses to a standardized bout of aerobic exercise in healthy adults. Prolonged moderate-to-high intensity exercise is known to acutely increase inflammatory activity, alter immune function, disrupt gastrointestinal integrity, and influence perceptions of recovery and anxiety. Nutritional interventions that can modulate these responses may be beneficial for supporting health and resilience in physically active populations. Postbiotics, which consist of non-viable microbial cells and their metabolic byproducts, have been proposed to influence immune and gastrointestinal function while avoiding some of the stability and safety concerns associated with live probiotics.

Approximately 50 healthy men and women aged 18 to 55 years will be recruited to participate in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Eligible participants will be randomly assigned to receive either a multi-strain postbiotic supplement or a matched placebo for 28 consecutive days. Both participants and investigators will remain blinded to treatment assignment for the duration of the study.

Participants will be instructed to maintain their habitual diet, physical activity, and lifestyle behaviors throughout the supplementation period and to avoid the use of additional probiotic, prebiotic, or immune-modulating supplements. Compliance with supplementation will be monitored by self-report and capsule counts.

At the end of the 28-day supplementation period, participants will complete a standardized 45-minute treadmill exercise bout performed at 75% of their individually determined maximum heart rate. This exercise protocol is designed to induce a controlled physiological stress that elicits measurable inflammatory, immune, and gastrointestinal responses.

Blood samples will be collected to assess biomarkers related to inflammation, immune function, and recovery. Gastrointestinal symptoms, intestinal permeability, anxiety, and perceived recovery will be assessed using validated questionnaires administered before and after the exercise challenge.

Safety will be monitored throughout the study through the collection of self-reported adverse events and investigator assessment.

This study will determine whether supplementation with a multi-strain postbiotic alters physiological and perceptual responses to prolonged aerobic exercise compared with placebo in healthy adults.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony M Hagele, MS; Phone Number: 6369494785; Email: ahagele@lindenwood.edu
• Study Contact Backup: Name: Joesi M Krieger, MS; Phone Number: 6369494785; Email: jmorey@lindenwood.edu

Study Locations

• United States
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Exercise and Performance Nutrition Laboratory
      • Principal Investigator: Chad M Kerksick, PhD
      • Contact: Anthony M Hagele, MS; Phone Number: 6369494785; Email: ahagele@lindenwood.edu
      • Contact: Joesi M Krieger, MS; Phone Number: 6369494785; Email: jmorey@lindenwood.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postbiotic; 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; 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.
Placebo Comparator: Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lindenwood University
• Investigators: Principal Investigator: Chad M Kerksick, PhD, Lindenwood University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: IRB-26-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data contain sensitive longitudinal biological and symptom information that cannot be reliably de-identified without compromising participant privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No