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 volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Multi-Strain Postbiotic
Dietary supplementParticipants 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 supplementParticipants 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
Trial outcomes
Primary outcomes
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
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
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
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.
Sponsors and contacts
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