Synbiotic Supplementation in Cyclists

University of Calgary

Status: Completed

Conditions: Exercise Endurance

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Synbiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06300060

REB23-1161

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Synbiotic

Experimental group

Description:

Participants receive the synbiotic for 6 weeks.

Treatment:

Dietary Supplement: Synbiotic

Placebo

Placebo Comparator group

Description:

Participants receive the placebo for 6 weeks.

Treatment:

Dietary Supplement: Placebo