Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-29 @ 8:50 AM
Study NCT ID:
NCT06186050
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a High-fat Meal on Exercise-mediated Sympatholysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forearm vascular conductance', 'timeFrame': 'Before intervention and 1, 2, 3 hours post-intervention', 'description': 'Duplex ultrasound of brachial artery'}, {'measure': 'Forearm blood flow', 'timeFrame': 'Before intervention and 1, 2, 3 hours post-intervention', 'description': 'Duplex ultrasound of brachial artery'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': 'Before intervention and 1, 2, 3 hours post-intervention', 'description': 'finger plethysmography'}], 'secondaryOutcomes': [{'measure': 'Plasma levels of Norepinephrine', 'timeFrame': 'Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date', 'description': 'ELISA kit'}, {'measure': 'Plasma levels of Nitrate/Nitrite concentration', 'timeFrame': 'Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date', 'description': 'ELISA kit'}, {'measure': 'Blood Glucose concentrations', 'timeFrame': 'Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood analyzed immediately after collection at each time point', 'description': 'Blood glucose monitor'}, {'measure': 'Plasma levels of Triglycerides', 'timeFrame': 'Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date', 'description': 'Triglyceride assay kit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional sympatholysis', 'Exercise'], 'conditions': ['Diet, Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to examine the effects of a single high-fat meal with or without the co-ingestion of dietary nitrate on exercise-mediated sympatholysis. The main questions it aims to answer are:\n\n1. What are the mechanisms responsible for reduced exercise-mediated sympatholysis following a high-fat meal\n2. Can dietary nitrate prevent the declines in exercise-mediated sympatholysis\n\nParticipants will be asked to complete three study visits in a randomized order:\n\n1. Low-fat meal\n2. High-fat meal\n3. High-fat meal plus dietary nitrate\n\nExercise-mediated sympatholysis will be measured using Doppler ultrasound via a protocol involving rhythmic handgrip exercise and a lower body negative pressure stimulus. Sympatholysis will be assessed before each meal, and at 1, 2, and 3 hours post-prandial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 years of age\n* Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease\n\nExclusion Criteria:\n\n* Diagnosed cardiovascular or metabolic disease, injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.\n* Inability to abstain from drugs (except oral contraceptives), caffeine, alcohol, strenuous physical activity, mouthwash, and multivitamins prior to study'}, 'identificationModule': {'nctId': 'NCT06186050', 'briefTitle': 'Effects of a High-fat Meal on Exercise-mediated Sympatholysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'Effects of a High-fat Meal on Exercise-mediated Sympatholysis', 'orgStudyIdInfo': {'id': '23-01-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-fat meal with Beetroot Drink', 'description': '2 sausage egg McMuffins and a hashbrown from McDonalds and 10g of beetroot powder mixed in 250 mL cold tap water drink', 'interventionNames': ['Dietary Supplement: Beetroot drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High-fat meal with Placebo Drink', 'description': '2 sausage egg McMuffins and a hashbrown from McDonalds and Mio water flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were mixed to match the beetroot supplement', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'SHAM_COMPARATOR', 'label': 'Low-fat meal control', 'description': 'Kelloggs cornflakes (110g), greek yogurt (400g), skim milk (500 mL), and orange juice (250 mL). Energy-matched to the high-fat meal', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Beetroot drink', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Superbeets'], 'description': 'Drink containing 10g of beetroot powder in 250 mL cold tap water', 'armGroupLabels': ['High-fat meal with Beetroot Drink']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Mio'], 'description': 'Mio flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were added to match the content in the beetroot supplement', 'armGroupLabels': ['High-fat meal with Placebo Drink']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low-fat meal with cornflakes, greek yogurt, skim milk, and orange juice', 'armGroupLabels': ['Low-fat meal control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G2W1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Guelph - Human Cardiovascular Physiology Laboratory', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'overallOfficials': [{'name': 'Philip Millar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Philip Millar', 'investigatorAffiliation': 'University of Guelph'}}}}