Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01034293
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-22', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose and insulin metabolism', 'timeFrame': '24 h'}], 'secondaryOutcomes': [{'measure': 'Substrate partitioning and metabolic markers', 'timeFrame': '24 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['feeding frequency', 'insulin metabolism', 'glucose metabolism', 'substrate partitioning'], 'conditions': ['Insulin', 'Glucose Metabolism']}, 'referencesModule': {'references': [{'pmid': '22719910', 'type': 'DERIVED', 'citation': 'Munsters MJ, Saris WH. Effects of meal frequency on metabolic profiles and substrate partitioning in lean healthy males. PLoS One. 2012;7(6):e38632. doi: 10.1371/journal.pone.0038632. Epub 2012 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: 18.5-25 kg/m2 (lean)\n* Gender: Male\n* Age: subjects has to be older than 18 and including 35 years old\n* Caucasian\n\nExclusion Criteria:\n\n* Metabolic abnormalities such as:\n\n 1. Lactose intolerant\n 2. Diabetes Mellitus\n 3. Hypertension\n 4. Hypotension\n 5. Cardiovascular diseases\n 6. Asthma and other obstructive pulmonary diseases\n 7. Elevated fasting blood glucose level'}, 'identificationModule': {'nctId': 'NCT01034293', 'briefTitle': 'Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning', 'orgStudyIdInfo': {'id': 'MEC 09-3-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low feeding frequency (3x)', 'interventionNames': ['Dietary Supplement: low feeding frequency (3x)']}, {'type': 'EXPERIMENTAL', 'label': 'High feeding frequency (14x)', 'interventionNames': ['Dietary Supplement: High feeding frequency (14x)']}], 'interventions': [{'name': 'low feeding frequency (3x)', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 meals a day', 'armGroupLabels': ['low feeding frequency (3x)']}, {'name': 'High feeding frequency (14x)', 'type': 'DIETARY_SUPPLEMENT', 'description': '14 meals a day', 'armGroupLabels': ['High feeding frequency (14x)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'University of Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'WHM Saris, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nederlandse Zuivel Organisatie', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. dr. WHM Saris', 'oldOrganization': 'University of Maastricht'}}}}