protocolSection identificationModule nctId: NCT06300060, orgStudyIdInfo id: REB23-1161, briefTitle: Synbiotic Supplementation in Cyclists, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Lallemand Health Solutions, descriptionModule briefSummary: 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., conditionsModule conditions: Exercise Endurance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel arm. Single-site, double-blinded, placebo-controlled trial., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, maskingDescription: The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Synbiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in endurance exercise performance measured during a 20km cycling distance trial, secondaryOutcomes measure: Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test, secondaryOutcomes measure: Change in peak power output (PPO) measured during a Step-Ramp-Step Test, secondaryOutcomes measure: Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP), secondaryOutcomes measure: Change in time to exhaustion measured during a cycling session at 85% of the peak power output, secondaryOutcomes measure: Change in fat and carbohydrate oxidation measured during exercise sessions, secondaryOutcomes measure: Change in blood lactate concentration measured via pinprick capillary blood test, secondaryOutcomes measure: Change in body composition measured by dual energy X-ray absorptiometry (DXA), secondaryOutcomes measure: Change in intestinal permeability markers measured in serum, secondaryOutcomes measure: Change in cytokines, secondaryOutcomes measure: Change in gastrointestinal symptoms measured by self-report, secondaryOutcomes measure: Change in fecal SCFA concentration measured by gas chromatography, secondaryOutcomes measure: Synbiotic strains quantification measured by qPCR in fecal matter, secondaryOutcomes measure: Change in fecal microbiota composition, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Calgary, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, contacts name: Raylene A Reimer, PhD, RD, role: CONTACT, phone: 403-220-8218, email: reimer@ucalgary.ca, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False