Postbiotic for Exercise Performance

(PBE Trial)

Overseen By Joesi M Krieger, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lindenwood University

Must not be taking: Antibiotics, Probiotics, Statins, Hypertension

Disqualifiers: Diabetes, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not clearly state if you need to stop taking your current medications. However, if you have recently changed your dosage of certain medications like statins, hypertension, or psychiatric drugs, you may not be eligible to participate.

What data supports the effectiveness of the treatment Postbiotic Active Lifestyle Blend for exercise performance?

Research shows that certain probiotics and postbiotics, like Lactiplantibacillus plantarum TWK10, can improve exercise performance and reduce fatigue. Additionally, postbiotics such as acetate and succinate have been found to enhance muscle energy use, which may support better exercise outcomes. ^{1 2 3 4 5}

Is the Postbiotic Active Lifestyle Blend safe for humans?

Research on probiotics, prebiotics, and synbiotics, which are similar to postbiotics, suggests they are generally safe for humans, including athletes and active individuals. Studies have shown positive health effects and no significant safety concerns, although more high-quality research is needed. ^{2 3 6 7 8}

How does the Postbiotic Active Lifestyle Blend treatment differ from other treatments for exercise performance?

The Postbiotic Active Lifestyle Blend is unique because it focuses on modulating gut microbiota to enhance exercise performance, unlike traditional methods that may not target gut health. This approach is similar to using probiotics, prebiotics, and synbiotics, which have shown potential in improving endurance and reducing inflammation in athletes. ^{2 8 9 10 11}

What is the purpose of this trial?

This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.

Research Team

Chad M Kerksick, PhD

Principal Investigator

Lindenwood University

Eligibility Criteria

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.

Inclusion Criteria

I am not currently being treated for any serious health issues, except those approved by the research team.

Signed informed consent

I agree to follow the study's rules and procedures.

Exclusion Criteria

Any condition or abnormality that, in the opinion of the investigator, would compromise participant safety or study data quality

Extensive travel (>1 month) that will disrupt the study protocol

Body mass index <18.5 to <29.9 kg/m2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either the postbiotic blend or a placebo for 8 weeks to assess effects on oxidative stress and exercise performance

8 weeks

Baseline, mid-study, and post-intervention assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Postbiotic Active Lifestyle Blend

Trial Overview 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.

Participant Groups

Group I: Postbiotic Active Lifestyle Blend Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Lindenwood University

Lead Sponsor

Trials

22

Recruited

830+

Archer Daniels Midland Co.

Industry Sponsor

Trials

3

Recruited

190+

Findings from Research

A systematic review of 1,204 participants found that pre-, pro-, and syn-biotic supplements did not significantly improve gastrointestinal permeability or symptoms at rest or during exercise, indicating limited efficacy for these interventions.

While prebiotic supplementation increased certain beneficial gut bacteria and short-chain fatty acids, probiotics mainly boosted the specific strains given without affecting overall gastrointestinal health markers, suggesting a need for more comprehensive studies with validated biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prebiotics, probiotics, and synbiotics on gastrointestinal outcomes in healthy adults and active adults at rest and in response to exercise-A systematic literature review. Rauch, CE., Mika, AS., McCubbin, AJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Gut check: Unveiling the influence of acute exercise on the gut microbiota. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of Lactobacillus casei Shirota ingestion on common cold infection and herpes virus antibodies in endurance athletes: a placebo-controlled, randomized trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of prebiotics, probiotics, and synbiotics on gastrointestinal outcomes in healthy adults and active adults at rest and in response to exercise-A systematic literature review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Different Impacts of Heat-Killed and Viable Lactiplantibacillus plantarum TWK10 on Exercise Performance, Fatigue, Body Composition, and Gut Microbiota in Humans. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Acetate and succinate benefit host muscle energetics as exercise-associated post-biotics. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

An Exploratory Investigation of Endotoxin Levels in Novice Long Distance Triathletes, and the Effects of a Multi-Strain Probiotic/Prebiotic, Antioxidant Intervention. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Prevention of excessive exercise-induced adverse effects in rats with Bacillus subtilis BSB3. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Probiotics, prebiotics and synbiotics: useful for athletes and active individuals? A systematic review. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum PS128 Improves Physiological Adaptation and Performance in Triathletes through Gut Microbiota Modulation. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Prebiotics and Synbiotics Supplementation on the Immune Function of Male University Football Players. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity enhances the improvement of body mass index and metabolism by inulin: a multicenter randomized placebo-controlled trial performed in obese individuals. [2022]