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Postbiotic

Postbiotic for Exercise Performance (PBE Trial)

Saint Charles, MO

N/A

Waitlist Available

Led By Chad M Kerksick, PhD

Research Sponsored by Lindenwood University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants between 18 - 45 years of age

Be between 18 and 65 years old

Must not have

Diagnosed with Type I or Type II diabetes (fasting blood glucose > 126 mg/dL)

Abnormality or obstruction of the gastrointestinal tract precluding swallowing or digestion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.

Summary

This trial will test the effects of a postbiotic blend on how the body responds to exercise in healthy adults.

Who is the study for?

This trial is for healthy adults who regularly exercise. It's designed to see if a postbiotic blend can help with muscle pain and improve gut health after working out. People with chronic diseases, taking certain medications, or unable to commit to the study schedule are not eligible.

What is being tested?

Participants will be randomly assigned to receive either a placebo or an active postbiotic blend. The study aims to determine if the postbiotic reduces oxidative stress and improves exercise performance in a double-blind setup where neither participants nor researchers know who receives what until the end.

What are the potential side effects?

Since this trial involves healthy individuals and a dietary supplement (postbiotic), side effects may be minimal but could include digestive discomfort or allergic reactions specific to ingredients in the blend.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes with a fasting blood sugar over 126 mg/dL.

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I cannot swallow or digest food properly due to a GI tract issue.

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I have not been hospitalized or needed home care for a major psychiatric disorder in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Serum Malondialdehyde Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion After 0 and 8 Weeks of Supplementation

Secondary study objectives

Change from Baseline in Blood Glucose Levels (mg/dL) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation

Change from Baseline in Blood Lactate Levels (mmol/L) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation

Change from Baseline in Carbohydrate Oxidation Rate (g/min) During Treadmill Running at 70-75% VO2Peak Assessed at 0, 15, 30, and 45 Minutes After 0 and 8 Weeks of Supplementation

+26 more

Other study objectives

Change from Baseline in Fecal Metabolomic Profile During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation

Change from Baseline in Gut Microbiome Composition Using Shotgun Metagenomic Sequencing (Fecal) During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Postbiotic Active Lifestyle BlendExperimental Treatment1 Intervention

Participants in this arm will receive the active Postbiotic Active Lifestyle Blend supplement, which contains a heat-treated blend of bacterial strains

Group II: PlaceboPlacebo Group1 Intervention

Participants in this arm will receive a placebo capsule that matches the appearance and dosage of the active blend.

0 / 4Eligibility criteria met