Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT06300060
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synbiotic Supplementation in Cyclists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel arm. Single-site, double-blinded, placebo-controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endurance exercise performance measured during a 20km cycling distance trial', 'timeFrame': '42 Days', 'description': 'Assessed as time (minutes) to complete 20km cycling distance'}], 'secondaryOutcomes': [{'measure': 'Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test', 'timeFrame': '36 Days', 'description': 'Assessed as mL·kg-1·min-1 measured through expired air collection'}, {'measure': 'Change in peak power output (PPO) measured during a Step-Ramp-Step Test', 'timeFrame': '36 Days', 'description': 'Assessed as highest power output in Watts'}, {'measure': 'Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP)', 'timeFrame': '36 Days', 'description': 'Assessed as power output in Watts at GET and RCP'}, {'measure': 'Change in time to exhaustion measured during a cycling session at 85% of the peak power output', 'timeFrame': '39 Days', 'description': 'Assessed as time (minutes) to reach volitional exhaustion.'}, {'measure': 'Change in fat and carbohydrate oxidation measured during exercise sessions', 'timeFrame': '36, 39 and 42 Days', 'description': 'Assessed with the nonprotein respiratory quotient equation using expired air variables (VO2 and VCO2)'}, {'measure': 'Change in blood lactate concentration measured via pinprick capillary blood test', 'timeFrame': '36, 39 and 42 Days', 'description': 'Assessed as mmol/L in capillary blood'}, {'measure': 'Change in body composition measured by dual energy X-ray absorptiometry (DXA)', 'timeFrame': '33 Days', 'description': 'Assessed as percent fat and muscle mass (%) with a DXA scan'}, {'measure': 'Change in intestinal permeability markers measured in serum', 'timeFrame': '33 Days', 'description': 'Assessed in serum as pg/ml (Zonulin, Irisin, and Claudin2)'}, {'measure': 'Change in cytokines', 'timeFrame': '33 Days', 'description': 'Assessed in serum as fg/ml (IFN-γ, IL-10, IL-12p70, IL-17, IL-1β, IL-2, IL-4, IL-6, TNF-α)'}, {'measure': 'Change in gastrointestinal symptoms measured by self-report', 'timeFrame': '33 Days', 'description': 'Assessed via subjective ratings on a Patient-Reported Outcomes Measurement Information System® (PROMIS®)-GI scale'}, {'measure': 'Change in fecal SCFA concentration measured by gas chromatography', 'timeFrame': '33 Days', 'description': 'Assessed as µmol/L of fecal SCFAs (acetate, butyrate, propionate, and total SCFAs)'}, {'measure': 'Synbiotic strains quantification measured by qPCR in fecal matter', 'timeFrame': '33 Days from Day 0', 'description': 'Assessed as 16S rRNA gene copies determined with qPCR'}, {'measure': 'Change in fecal microbiota composition', 'timeFrame': '33 Days', 'description': 'Assessed as relative abundance of the 16S rRNA amplicon obtained via sequencing'}, {'measure': 'Incidence of adverse events', 'timeFrame': '42 Days', 'description': 'Assessed as the number of adverse events and serious adverse events reported'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Cyclists', 'Athlete', 'Synbiotic', 'Prebiotic', 'Probiotic', 'Gut microbiota', 'Metabolism'], 'conditions': ['Exercise Endurance']}, '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.\n\nThe 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.', 'detailedDescription': '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:\n\n* Cycling performance\n* Exercise metabolism\n* Gastrointestinal health\n* Immune system\n* Body composition\n* Fecal Short Chain Fatty Acids (SCFAs)\n* Fecal microbiome composition\n\nParticipants 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).\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between the ages of 18-45\n* Currently cycling for at least 3 hours per week for the past 3 months\n* Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise\n* Have a resting heart rate \\<100 bpm and resting systolic and diastolic blood pressures \\<160 mmHg and \\<90 mmHg, respectively.\n\nExclusion Criteria:\n\n* Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)\n* Current laxative use\n* Are a smoker or use tobacco products\n* Consume \\>21 units of alcohol per week\n* Have donated blood in the previous 3 months\n* Have a BMI ≥30kg/m2\n* Are pregnant or lactating or planning to become pregnant for the duration of the study\n* Are dieting for weight loss or are following a low carbohydrate diet\n* Have participated in another clinical trial within the 30 days preceding study enrollment\n* Are taking medications known to affect cardiovascular or metabolic responses to exercise\n* Have a medical condition that could interfere with study intervention and assessment\n* Have current musculoskeletal injuries that limit exercise capacity\n* Are non-English speaking'}, 'identificationModule': {'nctId': 'NCT06300060', 'briefTitle': 'Synbiotic Supplementation in Cyclists', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial', 'orgStudyIdInfo': {'id': 'REB23-1161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synbiotic', 'description': 'Participants receive the synbiotic for 6 weeks.', 'interventionNames': ['Dietary Supplement: Synbiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive the placebo for 6 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Synbiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Combination of a probiotic and prebiotic. Daily administration in a single dose in powder form.', 'armGroupLabels': ['Synbiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo. Daily administration in a single dose in powder form.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Raylene A Reimer, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lallemand Health Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Raylene Reimer', 'investigatorAffiliation': 'University of Calgary'}}}}