Synbiotic Supplement for Exercise Endurance

Overseen By Raylene A Reimer, PhD, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Antibiotics, Probiotics, Laxatives, others

Disqualifiers: Smoking, High alcohol, High BMI, others

Compensation: Varies

Number of Visits: 16

Duration: 6 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance. The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.

Will I have to stop taking my current medications?

The trial requires that you do not take medications known to affect cardiovascular or metabolic responses to exercise. If you are on such medications, you may need to stop taking them to participate.

What data supports the effectiveness of the synbiotic treatment for exercise endurance?

Research shows that synbiotic supplements can improve immune function and reduce upper respiratory tract infections in athletes, which may indirectly support better exercise endurance. Additionally, synbiotics have been found to enhance physical activity and reduce stress and anxiety in athletes, potentially contributing to improved endurance. ^{1 2 3 4 5}

Is the synbiotic supplement safe for human use?

Research on synbiotic supplements, which combine probiotics and prebiotics, suggests they are generally safe for human use. Studies have shown positive effects on immune function and reduced respiratory infections in athletes, with no significant adverse effects reported. ^{1 2 3 4 6}

How does the synbiotic treatment for exercise endurance differ from other treatments?

The synbiotic treatment is unique because it combines probiotics (beneficial bacteria) and prebiotics (food for these bacteria) to potentially enhance exercise endurance by improving gut health and immune function, which is not a focus of traditional endurance treatments. ^{1 2 7 8 9}

Research Team

Raylene A Reimer, PhD, RD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for trained adult cyclists who want to see if a synbiotic blend (a mix of probiotics and prebiotics) can improve their endurance. Participants should be healthy, with no medical conditions that affect exercise performance.

Inclusion Criteria

I have no health issues that prevent me from exercising.

Currently cycling for at least 3 hours per week for the past 3 months

Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively.

Exclusion Criteria

BMI ≥30kg/m2

Donated blood in the previous 3 months

I have injuries that prevent me from exercising.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

4 visits (in-person)

Pre-testing

Baseline assessments conducted before randomization

1 week

4 visits (in-person)

Treatment

Participants receive the synbiotic or placebo for 6 weeks

6 weeks

4 visits (in-person)

Post-testing

Post-intervention assessments conducted to evaluate outcomes

1 week

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Synbiotic

Trial Overview The study is testing whether taking a synbiotic supplement can help cyclists perform better on a 20km distance trial. It will also look at how the supplement might affect metabolism, body composition, gut health, and immune system during exercise.

Participant Groups

Group I: Synbiotic Experimental Treatment 1 Intervention

Participants receive the synbiotic for 6 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants receive the placebo for 6 weeks.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Lallemand Health Solutions

Industry Sponsor

Trials

44

Recruited

4,100+

Founded

1934

Headquarters

Mirabel, Canada

Known For

Microbiome therapies

Top Products

Lacidofil, ProbioKid, Probio'Stick, IBacilluS+

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]

In a trial with 15 healthy volunteers, a 4-week synbiotic intervention combining specific probiotics and chicory-derived inulin showed no adverse effects, indicating its safety for consumption.

The intervention led to an increase in the abundance of beneficial gut bacteria, particularly Bifidobacteriaceae, while the overall diversity of the gut microbiome remained unchanged, suggesting targeted effects of the synbiotics on gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. Rubin, IMC., Mollerup, S., Broholm, C., et al.[2023]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Differential Health Effects on Inflammatory, Immunological and Stress Parameters in Professional Soccer Players and Sedentary Individuals after Consuming a Synbiotic. A Triple-Blinded, Randomized, Placebo-Controlled Pilot Study. [2022]

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

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. [2023]

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

Supplementation of Probiotics and Its Effects on Physically Active Individuals and Athletes: Systematic Review. [2019]

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

Immune status, well-being and gut microbiota in military supplemented with synbiotic ice cream and submitted to field training: a randomised clinical trial. [2022]

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

Gut Balance, a synbiotic supplement, increases fecal Lactobacillus paracasei but has little effect on immunity in healthy physically active individuals. [2021]

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

Bifidobacterium longum subsp. longum OLP-01 Supplementation during Endurance Running Training Improves Exercise Performance in Middle- and Long-Distance Runners: A Double-Blind Controlled Trial. [2021]