CompletedNot Applicable

Synbiotic Supplementation in Cyclists

Canada22 participantsStarted 2024-07-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 42 Days

Trial details

NCT IDNCT06300060

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-23

View on ClinicalTrials.gov More Exercise Endurance trials