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Completed

NCT Number: NCT06300060

Synbiotic Supplementation in Cyclists

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

The goal of this randomized double-blinded clinical trial is to evaluate the potential beneficial effects of a synbiotic formulation on exercise performance in trained adult cyclists. The main questions it aims to answer are related to the Synbiotic effects on:

  • Cycling performance
  • Exercise metabolism
  • Gastrointestinal health
  • Immune system
  • Body composition
  • Fecal Short Chain Fatty Acids (SCFAs)
  • Fecal microbiome composition

Participants will be recruited and, if consenting and eligible, will undergo the initial pre-testing phase for baseline assessment (4 on-site visits). Then, they will be randomized to receive the synbiotic or placebo and instructed to consume one sachet daily for 42 consecutive days. After 4-5 weeks of intervention (Day 33), post-testing phase will start, and participants will be asked to return to the site to perform post testing assessments (over 4 on-site visits). Study visits will occur as follows, V1 (Day -9), V2 (Day -6), V3 (Day -3), V4 (Day 0), V5 (Day 33), V6 (Day 36), V7 (Day 39), and V8 (Day 42).

Researchers will compare the assessed outcomes to baseline in each group and evaluate the difference between groups following the synbiotic consumption to highlight any statistically and clinically relevant observations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female between the ages of 18-45
  • Currently cycling for at least 3 hours per week for the past 3 months
  • Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise
  • Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively.

Exclusion criteria

  • Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)
  • Current laxative use
  • Are a smoker or use tobacco products
  • Consume >21 units of alcohol per week
  • Have donated blood in the previous 3 months
  • Have a BMI ≥30kg/m2
  • Are pregnant or lactating or planning to become pregnant for the duration of the study
  • Are dieting for weight loss or are following a low carbohydrate diet
  • Have participated in another clinical trial within the 30 days preceding study enrollment
  • Are taking medications known to affect cardiovascular or metabolic responses to exercise
  • Have a medical condition that could interfere with study intervention and assessment
  • Have current musculoskeletal injuries that limit exercise capacity
  • Are non-English speaking

Treatment and study plan

Synbiotic

Dietary Supplement

Combination of a probiotic and prebiotic. Daily administration in a single dose in powder form.

Placebo

Dietary Supplement

Placebo. Daily administration in a single dose in powder form.

Primary outcomes

  1. Change in endurance exercise performance measured during a 20km cycling distance trial

    Time frame: 42 Days

    Assessed as time (minutes) to complete 20km cycling distance

Secondary outcomes

  1. Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test

    Time frame: 36 Days

    Assessed as mL·kg-1·min-1 measured through expired air collection

  2. Change in peak power output (PPO) measured during a Step-Ramp-Step Test

    Time frame: 36 Days

    Assessed as highest power output in Watts

  3. Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP)

    Time frame: 36 Days

    Assessed as power output in Watts at GET and RCP

  4. Change in time to exhaustion measured during a cycling session at 85% of the peak power output

    Time frame: 39 Days

    Assessed as time (minutes) to reach volitional exhaustion.

  5. Change in fat and carbohydrate oxidation measured during exercise sessions

    Time frame: 36, 39 and 42 Days

    Assessed with the nonprotein respiratory quotient equation using expired air variables (VO2 and VCO2)

  6. Change in blood lactate concentration measured via pinprick capillary blood test

    Time frame: 36, 39 and 42 Days

    Assessed as mmol/L in capillary blood

  7. Change in body composition measured by dual energy X-ray absorptiometry (DXA)

    Time frame: 33 Days

    Assessed as percent fat and muscle mass (%) with a DXA scan

  8. Change in intestinal permeability markers measured in serum

    Time frame: 33 Days

    Assessed in serum as pg/ml (Zonulin, Irisin, and Claudin2)

  9. Change in cytokines

    Time frame: 33 Days

    Assessed in serum as fg/ml (IFN-γ, IL-10, IL-12p70, IL-17, IL-1β, IL-2, IL-4, IL-6, TNF-α)

  10. Change in gastrointestinal symptoms measured by self-report

    Time frame: 33 Days

    Assessed via subjective ratings on a Patient-Reported Outcomes Measurement Information System® (PROMIS®)-GI scale

  11. Change in fecal SCFA concentration measured by gas chromatography

    Time frame: 33 Days

    Assessed as µmol/L of fecal SCFAs (acetate, butyrate, propionate, and total SCFAs)

  12. Synbiotic strains quantification measured by qPCR in fecal matter

    Time frame: 33 Days from Day 0

    Assessed as 16S rRNA gene copies determined with qPCR

  13. Change in fecal microbiota composition

    Time frame: 33 Days

    Assessed as relative abundance of the 16S rRNA amplicon obtained via sequencing

  14. Incidence of adverse events

    Time frame: 42 Days

    Assessed as the number of adverse events and serious adverse events reported

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Lallemand Health Solutions

Registry information

Official study title

The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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