Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-03 @ 5:57 PM
Study NCT ID:
NCT01886495
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013631', 'term': 'Tangier Disease'}], 'ancestors': [{'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adiponectin (mcg/ml)', 'timeFrame': '10 weeks', 'description': 'amount of adiponectin'}], 'secondaryOutcomes': [{'measure': 'interlukine 6 (mcg/ml)', 'timeFrame': '10 weeks'}, {'measure': 'tumor necrosis factor alpha (ng/ml)', 'timeFrame': '10 weeks'}, {'measure': 'C reactive protein (mcg/ml)', 'timeFrame': '10 weeks'}, {'measure': 'fibrinogen (mcg/ml)', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Body Mass Index Quantitative Trait Locus 5 Disorder', 'Tangier Disease']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 85th\n* age of 6-11 years\n* no history of chronic diseases\n* taken medications\n\nExclusion Criteria:\n\n* do not prescribe their diet\n* mental retardation'}, 'identificationModule': {'nctId': 'NCT01886495', 'briefTitle': 'Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'High Protein Diet , Adiponectin and Inflammatory Factors', 'orgStudyIdInfo': {'id': 'high protein diet in children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nutrition intervention', 'description': 'high protein diet', 'interventionNames': ['Other: nutrition intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control diet'}], 'interventions': [{'name': 'nutrition intervention', 'type': 'OTHER', 'otherNames': ['high protein diet'], 'armGroupLabels': ['nutrition intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'country': 'Iran', 'facility': 'Isfahan University of Medical Sciences Leila Azadbakht, Phd', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'Leila Azadbakht, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Isfahan University of Medical Sciences', 'investigatorFullName': 'Leila Azadbakht', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}