Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT00694512
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2008-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D059305', 'term': 'Diet, High-Fat'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-14', 'studyFirstSubmitDate': '2008-06-06', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcomes for aim 1 are the suppression of total and acylated ghrelin from peak fasting (highest value) level to nadir (lowest level) during the 4 hours after each meal, comparing the obese to the lean subjects.', 'timeFrame': 'every 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Area-under-the-curve measurements during the 12 ½ hours of testing for ghrelin and other nutrient and gut-peptides, including glucose, insulin, PYY3-36, and active GLP-1.', 'timeFrame': 'Every 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about how diet affects the hormone ghrelin. Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will help the investigators understand more about obesity.', 'detailedDescription': 'Control subjects will be provided 3 different diets for 2 weeks each. At the end of each diet period participants will be admitted to OHSU Clinical Translation Research Center (CTRC) for blood sampling every 30 minutes for 13.5 hours, to measure levels of hormones. Participants will also have a DXA scan to measure body composition.\n\nPWS subjects will have one admission after eating a standardized diet prepared by caregivers for 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older.\n* Weight stable for at least 3 months.\n* At lifetime maximal body weight.\n\nExclusion Criteria:\n\n* Actively losing weight by diet or exercise.\n* Smokers.\n* Alcohol consumption \\> 2 drinks per day.\n* Exercise \\> 30 minutes 3 times a week.\n* Prescription drug use (except birth control pills, vitamins, or minerals).\n* Type 2 diabetes.\n* Heart disease, cancer, malabsorptive states, or chronic infections that would affect body weight.\n* Weight \\> 300 lbs (exceeds the weight limit of the DEXA machine).\n* Hemoglobin \\< 12.0 g/dL for women, \\< 13.5 g/dL for men'}, 'identificationModule': {'nctId': 'NCT00694512', 'briefTitle': 'Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin', 'orgStudyIdInfo': {'id': 'eIRB 3224'}, 'secondaryIdInfos': [{'id': 'OCTRI 1048', 'type': 'OTHER', 'domain': 'Oregon Clinical and Translational Research Institute'}, {'id': 'eIRB #3224', 'type': 'OTHER', 'domain': 'OHSU Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'low fat diet for two weeks.', 'interventionNames': ['Dietary Supplement: Low fat diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'High fat diet for two weeks followed by blood sampling.', 'interventionNames': ['Dietary Supplement: High fat diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Medium Chain Triglyceride diet', 'interventionNames': ['Dietary Supplement: MCT diet']}], 'interventions': [{'name': 'Low fat diet', 'type': 'DIETARY_SUPPLEMENT', 'description': '20% fat diet', 'armGroupLabels': ['1']}, {'name': 'High fat diet', 'type': 'DIETARY_SUPPLEMENT', 'description': '40% fat diet', 'armGroupLabels': ['2']}, {'name': 'MCT diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Medium chain triglyceride diet'], 'description': 'Medium chain triglyceride diet', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Jonathan Q. Purnell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jonathan Q. Purnell', 'oldOrganization': 'OHSU - Center for the Study of Weight Regulation'}}}}