Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 2:34 AM
Study NCT ID:
NCT02506218
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Meal and Snack Timing to Promote Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma amino acid concentration', 'timeFrame': '7 weeks', 'description': 'Peak plasma concentration of amino acids'}], 'secondaryOutcomes': [{'measure': 'Blood glucose concentration', 'timeFrame': '7 weeks', 'description': 'Area under the curve of blood glucose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dietary Modification']}, 'descriptionModule': {'briefSummary': 'This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a catheter and collect blood samples from an antecubital vein using sterile techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n25-39 years old\n\n* BMI between 22-37 kg/m2\n* Weight stable (± 4.5 kg) for the previous 3 months\n* Not currently (or within the past 6 months) following a vigorous exercise regimen or weight loss program\n* No acute illness\n* Not smoking\n* Not diabetic\n* Not pregnant or planning pregnancy in the next 3 months\n* Lactose tolerant\n* Willing to limit purposeful activity for 48 hours prior to each testing day\n* Willing to consume study foods and beverages.\n\nExclusion Criteria:\n\n* \\<25 or \\>39 years old, BMI \\<22 or \\>37 kg/m2\n* Currently (or within the past 6 months) following a vigorous exercise regimen greater than -3 - 45 minute exercise sessions per week\n* Currently following a weight loss program where subject has lost greater than 4.5 kg\n* Acute illness\n* Smoking\n* Diabetic\n* Pregnant or planning pregnancy in the next 3 months\n* Lactose intolerant\n* Unwilling to consume study foods and beverages\n* Peri and post-menopausal women.'}, 'identificationModule': {'nctId': 'NCT02506218', 'acronym': 'S43', 'briefTitle': 'Optimizing Meal and Snack Timing to Promote Health', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Optimizing Meal and Snack Timing to Promote Health', 'orgStudyIdInfo': {'id': '1501015661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 + 20 g protein consumption', 'description': '10 g breakfast followed by the consumption of a 20g whey protein shake', 'interventionNames': ['Dietary Supplement: 10 + 20 g protein consumption']}, {'type': 'ACTIVE_COMPARATOR', 'label': '30 g protein breakfast', 'interventionNames': ['Other: 30 g protein breakfast']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 g protein breakfast', 'interventionNames': ['Other: 10 g protein breakfast']}], 'interventions': [{'name': '10 + 20 g protein consumption', 'type': 'DIETARY_SUPPLEMENT', 'description': 'whey isolate', 'armGroupLabels': ['10 + 20 g protein consumption']}, {'name': '30 g protein breakfast', 'type': 'OTHER', 'description': '30 g mixed meal breakfast', 'armGroupLabels': ['30 g protein breakfast']}, {'name': '10 g protein breakfast', 'type': 'OTHER', 'description': '10 g mixed meal breakfast', 'armGroupLabels': ['10 g protein breakfast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Nutrition Science', 'investigatorFullName': 'Wayne Campbell', 'investigatorAffiliation': 'Purdue University'}}}}