University of Calgary
Calgary, Alberta, T2N 1N4, Canada
NCT Number: NCT06300060
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Calgary, Alberta, T2N 1N4, Canada
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Combination of a probiotic and prebiotic. Daily administration in a single dose in powder form.
Placebo. Daily administration in a single dose in powder form.
Time frame: 42 Days
Assessed as time (minutes) to complete 20km cycling distance
Time frame: 36 Days
Assessed as mL·kg-1·min-1 measured through expired air collection
Time frame: 36 Days
Assessed as highest power output in Watts
Time frame: 36 Days
Assessed as power output in Watts at GET and RCP
Time frame: 39 Days
Assessed as time (minutes) to reach volitional exhaustion.
Time frame: 36, 39 and 42 Days
Assessed with the nonprotein respiratory quotient equation using expired air variables (VO2 and VCO2)
Time frame: 36, 39 and 42 Days
Assessed as mmol/L in capillary blood
Time frame: 33 Days
Assessed as percent fat and muscle mass (%) with a DXA scan
Time frame: 33 Days
Assessed in serum as pg/ml (Zonulin, Irisin, and Claudin2)
Time frame: 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)
Time frame: 33 Days
Assessed via subjective ratings on a Patient-Reported Outcomes Measurement Information System® (PROMIS®)-GI scale
Time frame: 33 Days
Assessed as µmol/L of fecal SCFAs (acetate, butyrate, propionate, and total SCFAs)
Time frame: 33 Days from Day 0
Assessed as 16S rRNA gene copies determined with qPCR
Time frame: 33 Days
Assessed as relative abundance of the 16S rRNA amplicon obtained via sequencing
Time frame: 42 Days
Assessed as the number of adverse events and serious adverse events reported
University of Calgary
Other
The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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