Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 3:20 AM
Study NCT ID:
NCT05618756
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBD, Nutrient Metabolism and Energy Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D001070', 'term': 'Appetitive Behavior'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy intake', 'timeFrame': '~5-30 minutes (time taken to eat a single meal)', 'description': 'Self-selected energy intake at an ad libitum mixed meal'}, {'measure': 'Postprandial Glycaemia', 'timeFrame': '3 hours', 'description': 'Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)'}, {'measure': 'Postprandial Triglyceridaemia', 'timeFrame': '3 hours', 'description': 'Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)'}], 'secondaryOutcomes': [{'measure': 'Postprandial Insulinaemia', 'timeFrame': '3 hours', 'description': 'Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glucose Metabolism Disorders (Including Diabetes Mellitus)', 'Lipid Metabolism Disorders', 'Appetitive Behavior']}, 'descriptionModule': {'briefSummary': 'CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and \\<30.0\n\nExclusion Criteria:\n\n* Currently engage in \\>10 hours moderate or vigorous intensity physical activity per week\n* Have consumed CBD or cannabis at all within the past two months\n* Have used CBD or cannabis regularly (\\>2x in a week) within the past four months\n* Are suffering from any clinically significant illness\n* Have regularly used tobacco within the previous 6 months (\\> 2/week)\n* Currently use any prescription or over-the-counter medications (except for hormonal contraception and simple painkillers)\n* Have given a standard blood donation within 30 days of screening\n* Are currently pregnant or lactating\n* Are allergic/intolerant to any ingredients in food items provided during the study'}, 'identificationModule': {'nctId': 'NCT05618756', 'briefTitle': 'CBD, Nutrient Metabolism and Energy Intake', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults', 'orgStudyIdInfo': {'id': '5553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cannabidiol', 'description': '300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules.', 'interventionNames': ['Dietary Supplement: Acute oral CBD supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 ml hemp oil. Provided orally in gelatin capsules.', 'interventionNames': ['Dietary Supplement: Acute oral placebo supplementation']}], 'interventions': [{'name': 'Acute oral CBD supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.', 'armGroupLabels': ['Cannabidiol']}, {'name': 'Acute oral placebo supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE11 3TU', 'city': 'Loughborough', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Loughborough University', 'geoPoint': {'lat': 52.76667, 'lon': -1.2}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loughborough University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer in Nutrition', 'investigatorFullName': 'Lewis James', 'investigatorAffiliation': 'Loughborough University'}}}}