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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLindenwood University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PostbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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.
2

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

Time frame
Serum TNF-α concentrations will be measured using multiplex bead-based assays to assess exercise-induced inflammatory responses following supplementation.
3

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

Time frame
Serum IL-10 concentrations will be measured to assess anti-inflammatory and immune regulatory responses to exercise following supplementation.
4

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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