Synbiotic Supplementation in Cyclists

NCT06300060 | Completed

• 1 other identifier: REB23-1161
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Endurance

Keywords

Exercise; Cyclists; Athlete; Synbiotic; Prebiotic; Probiotic; Gut microbiota; Metabolism

Outcome Measures

Primary Outcomes (1)

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

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

  42 Days

Secondary Outcomes (14)

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

  36 Days

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

  36 Days

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

  36 Days

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

  39 Days

• Change in fat and carbohydrate oxidation measured during exercise sessions

  36, 39 and 42 Days

Study Arms (2)

Synbiotic

EXPERIMENTAL

Participants receive the synbiotic for 6 weeks.

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

Participants receive the placebo for 6 weeks.

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

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

Synbiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Raylene A Reimer, PhD, RD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel arm. Single-site, double-blinded, placebo-controlled trial.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 8, 2024
• Study Start: July 15, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)