Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT00625235
Status:
COMPLETED
Last Update Posted:
2008-02-28
First Post:
2008-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A High Protein Diet and Weight Maintenance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-06', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-19', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular risk factors', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Weight loss', 'Weight maintenance', 'VLED'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy men and women with a BMI \\>27kg/m2 with co-morbities or BMI \\>30kg/m2\n\nExclusion Criteria:\n\n* people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT00625235', 'briefTitle': 'A High Protein Diet and Weight Maintenance', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'officialTitle': 'The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors', 'orgStudyIdInfo': {'id': 'HREC 2003.046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'High Carbohydrate diet', 'interventionNames': ['Dietary Supplement: VLED followed by a high protein or high carbohydrate diet']}, {'type': 'OTHER', 'label': '2', 'description': 'High Protein diet', 'interventionNames': ['Dietary Supplement: VLED followed by a high protein or high carbohydrate diet']}], 'interventions': [{'name': 'VLED followed by a high protein or high carbohydrate diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3081', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Department of Medicine, Heidelberg Repatriation Hospital', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meat and Livestock Australia', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldOrganization': 'Meat and Livestock Australia'}}}}