Synbiotic Supplementation in Cyclists
- Conditions
- Exercise Endurance
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Synbiotic
- Registration Number
- NCT06300060
- Lead Sponsor
- University of Calgary
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants receive the placebo for 6 weeks. Synbiotic Synbiotic Participants receive the synbiotic for 6 weeks.
- Primary Outcome Measures
Name Time Method Change in endurance exercise performance measured during a 20km cycling distance trial 42 Days Assessed as time (minutes) to complete 20km cycling distance
- Secondary Outcome Measures
Name Time Method Change in peak power output (PPO) measured during a Step-Ramp-Step Test 36 Days Assessed as highest power output in Watts
Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP) 36 Days Assessed as power output in Watts at GET and RCP
Synbiotic strains quantification measured by qPCR in fecal matter 33 Days from Day 0 Assessed as 16S rRNA gene copies determined with qPCR
Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test 36 Days Assessed as mL·kg-1·min-1 measured through expired air collection
Change in body composition measured by dual energy X-ray absorptiometry (DXA) 33 Days Assessed as percent fat and muscle mass (%) with a DXA scan
Change in cytokines 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)
Change in gastrointestinal symptoms measured by self-report 33 Days Assessed via subjective ratings on a Patient-Reported Outcomes Measurement Information System® (PROMIS®)-GI scale
Change in fecal SCFA concentration measured by gas chromatography 33 Days Assessed as µmol/L of fecal SCFAs (acetate, butyrate, propionate, and total SCFAs)
Change in fat and carbohydrate oxidation measured during exercise sessions 36, 39 and 42 Days Assessed with the nonprotein respiratory quotient equation using expired air variables (VO2 and VCO2)
Change in blood lactate concentration measured via pinprick capillary blood test 36, 39 and 42 Days Assessed as mmol/L in capillary blood
Change in time to exhaustion measured during a cycling session at 85% of the peak power output 39 Days Assessed as time (minutes) to reach volitional exhaustion.
Change in intestinal permeability markers measured in serum 33 Days Assessed in serum as pg/ml (Zonulin, Irisin, and Claudin2)
Change in fecal microbiota composition 33 Days Assessed as relative abundance of the 16S rRNA amplicon obtained via sequencing
Incidence of adverse events 42 Days Assessed as the number of adverse events and serious adverse events reported
Trial Locations
- Locations (1)
University of Calgary
🇨🇦Calgary, Alberta, Canada