Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-04 @ 4:05 PM
Study NCT ID:
NCT06821620
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062408', 'term': 'Breakfast'}], 'ancestors': [{'id': 'D062407', 'term': 'Meals'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Breakfast condition - high carbohydrate or protein enriched'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose response', 'timeFrame': '120 minutes', 'description': 'Area under the curve'}], 'secondaryOutcomes': [{'measure': 'CGM metrics - mean glucose', 'timeFrame': '14 days', 'description': 'mean glucose for 14 days measured using (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)'}, {'measure': 'CGM metrics - Time in range', 'timeFrame': '14 days', 'description': 'Time in range for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)'}, {'measure': 'CGM metrics - glycaemic variability', 'timeFrame': '14 days', 'description': 'glycaemic variability for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'The risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. Previous research suggests eating a protein enriched breakfast can improve glucose response. Therefore, the present study will investigate if the version of the MTNR1B gene that people have is associated with their glucose response after breakfast. Also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. Measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. These findings can be used to provide personalised nutrition advice which may reduce the risk of T2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-48 years\\*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers.\n\nExclusion Criteria:\n\n* aged \\< 18 or \\> 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.'}, 'identificationModule': {'nctId': 'NCT06821620', 'briefTitle': 'Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.', 'organization': {'class': 'OTHER', 'fullName': "St. Mary's University, Twickenham"}, 'officialTitle': 'Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.', 'orgStudyIdInfo': {'id': 'SMU_ETHICS_2023-24_626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein enriched breakfast', 'interventionNames': ['Dietary Supplement: Breakfast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High carbohydrate breakfast', 'interventionNames': ['Dietary Supplement: Breakfast']}], 'interventions': [{'name': 'Breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Breakfast in one condition will be high carbohydrate and in the other protein enriched', 'armGroupLabels': ['High carbohydrate breakfast', 'Protein enriched breakfast']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': "St Mary's University", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Mary's University, Twickenham", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}