Clinical trial NCT06300060: Synbiotic Supplementation in Cyclists
Official title: The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: a Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exercise Endurance
Keywords: Exercise
Cyclists
Athlete
Synbiotic
Prebiotic
Probiotic
Gut microbiota
Metabolism
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Lallemand Health Solutions
First posted: 2024-03-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel arm. Single-site, double-blinded, placebo-controlled trial.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in endurance exercise performance measured during a 20km cycling distance trial
timeFrame: 42 Days
Secondary outcomes:
measure: Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test
timeFrame: 36 Days
measure: Change in peak power output (PPO) measured during a Step-Ramp-Step Test
timeFrame: 36 Days
measure: Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP)
timeFrame: 36 Days
measure: Change in time to exhaustion measured during a cycling session at 85% of the peak power output
timeFrame: 39 Days
measure: Change in fat and carbohydrate oxidation measured during exercise sessions
timeFrame: 36, 39 and 42 Days
measure: Change in blood lactate concentration measured via pinprick capillary blood test
timeFrame: 36, 39 and 42 Days
measure: Change in body composition measured by dual energy X-ray absorptiometry (DXA)
timeFrame: 33 Days
measure: Change in intestinal permeability markers measured in serum
timeFrame: 33 Days
measure: Change in cytokines
timeFrame: 33 Days
measure: Change in gastrointestinal symptoms measured by self-report
timeFrame: 33 Days
measure: Change in fecal SCFA concentration measured by gas chromatography
timeFrame: 33 Days
measure: Synbiotic strains quantification measured by qPCR in fecal matter
timeFrame: 33 Days from Day 0
measure: Change in fecal microbiota composition
timeFrame: 33 Days
measure: Incidence of adverse events
timeFrame: 42 Days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene A Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: