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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a synbiotic supplement can boost exercise performance, particularly endurance, in trained cyclists. Researchers will compare performance in a 20km cycling trial between cyclists taking the synbiotic and those taking a placebo. They will also examine effects on body composition, metabolism, and gut and immune health. Cyclists who have trained for at least 3 hours a week for the past 3 months and have no conditions affecting exercise or metabolism are ideal candidates for this trial. As an unphased trial, this study offers cyclists the chance to contribute to innovative research on exercise performance and 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that synbiotic supplements, which combine probiotics and prebiotics, are generally safe for most people. Studies indicate they rarely cause side effects. Occasionally, mild issues like nausea and bloating might occur, but these are uncommon. Probiotics, a key part of synbiotics, have a strong safety record. Most clinical trials reported very few negative effects. Overall, current evidence suggests the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the synbiotic supplement because it offers a novel approach to enhancing exercise endurance. Unlike common endurance boosters like caffeine or creatine, which primarily focus on energy production or muscle recovery, synbiotics work by improving gut health. This unique mechanism involves a combination of probiotics and prebiotics that may optimize nutrient absorption and reduce inflammation, potentially leading to better performance and faster recovery. By targeting the gut microbiome, synbiotics could provide a more sustainable and natural boost to endurance without the side effects associated with stimulants.

What evidence suggests that this synbiotic is effective for improving exercise endurance?

Research has shown that synbiotic supplements, which combine helpful bacteria (probiotics) and food for those bacteria (prebiotics), may improve exercise performance. One study found that athletes taking synbiotics performed better in high-speed sprints than those who didn't. Another study discovered that probiotics alone helped athletes improve their endurance and body composition, although the exact reasons remain unclear. Additionally, taking probiotics with regular exercise has increased muscle strength and boosted overall physical performance. This trial will compare the effects of a synbiotic supplement with a placebo on cyclists' endurance. While researchers continue to study the effects of synbiotics on cyclists' endurance, early results are promising. ^{2 6 7 8 9}

Who Is on the Research Team?

Raylene A Reimer, PhD, RD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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

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.

I have no health issues that prevent me from exercising.

Exclusion Criteria

BMI ≥30kg/m2

Donated blood in the previous 3 months

I have injuries that prevent me from exercising.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12473082/

Synbiotic Supplementation with Probiotics and Omega-3 ...

Results: The synbiotic group showed greater improvements in high-velocity, sprint-relevant measures versus comparators—higher 180°/s torque and ...

2.

withpower.com

withpower.com/trial/phase-exercise-endurance-3-2024-6e382

Synbiotic Supplement for Exercise Endurance

It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1728869X2400039X

Effects of probiotic supplementation on 12 min run ...

Probiotic supplementation has a positive effect on endurance exercise performance and body composition in athletes, but the underlying mechanisms remain unclear ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11133216/

An Updated View of the Effect of Probiotic Supplement on ...

Physical performance, Combination of probiotic supplementation and exercise improved physical performance by increasing muscle strength in both legs, [123].

5.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08130-9

Investigating the effects of synbiotic supplementation ... - Trials

Secondary outcomes include changes in body composition, muscle mass and architecture, fecal microbiota composition and diversity, and fecal and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8957944/

Best Practices for Probiotic Research in Athletic and ...

Comprehensive safety and tolerability data (e.g., nausea, flatulence, bloating, cramps, borborygmi, and gastric reflux) will need to be collected during ...

7.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06552-x

Impact of probiotic supplementation on exercise endurance ...

The primary objective of this study is to assess the ergogenic effects of a probiotic on high-intensity endurance running performance in non-elite runners.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2095254622001260

A systematic scoping review of study methodology for ...

Probiotic supplements have an excellent safety profile, with many clinical trials showing very few side effects or adverse events following probiotic ...

9.

physoc.onlinelibrary.wiley.com

physoc.onlinelibrary.wiley.com/doi/10.14814/phy2.70288

The effects of probiotic supplementation on body composition ...

Probiotic supplementation can have significant effects on body composition and exercise performance. Due to the moderate-to-low certainty of evidence, further ...