Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-29 @ 5:24 AM
Study NCT ID:
NCT00686192
Status:
COMPLETED
Last Update Posted:
2008-07-22
First Post:
2008-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium and Lipid Metabolism
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': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-21', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipolysis by infusion of stable isotopes of 1,1,2,3,3-[2H5] glycerol', 'timeFrame': '0 and 3 months'}], 'secondaryOutcomes': [{'measure': 'Hepatic glucose production by infusion of stable isotopes of 6,6-[2H2] glucose', 'timeFrame': '0 and 3 months'}, {'measure': 'Lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA)', 'timeFrame': '0 and 3 months'}, {'measure': 'Indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation', 'timeFrame': '0 and 3 months'}, {'measure': 'Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D', 'timeFrame': '0 and 3 months'}, {'measure': 'urinary calcium and sodium excretion', 'timeFrame': '0 and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Calcium carbonate', 'Dietary Supplements', 'Lipolysis'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ars.usda.gov/main/site_main.htm?modecode=53062500', 'label': 'USDA Western Human Nutrition Research Center'}]}, 'descriptionModule': {'briefSummary': 'We hope to determine if supplementing the diet of women who habitually consume low levels of calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and enzymes associated with fat and carbohydrate metabolism to determine alterations and mechanism of the metabolic changes.', 'detailedDescription': 'The incidence of obesity has rapidly increased in recent years and reached epidemic proportions in the United States. Recent epidemiological data has shown an inverse relationship between calcium intake and body fat and emerging research suggests that inadequate dietary calcium consumption may increase obesity. Studies in mice have shown that an increase in dietary calcium consumption creates a shift in the utilization of energy stores from carbohydrates to fat and a shift in the partitioning of energy from storage (as fat) to expenditure (as heat).\n\nWe will give 1500 mg of calcium a day for three months to women who habitually consume low levels of dietary calcium. The following measurements will be made before and after calcium supplementation: body fat by DEXA, lipolysis by infusion of stable isotopes of 1,1,2,3,3-\\[2H5\\] glycerol , hepatic glucose production by infusion of stable isotopes of 6,6-\\[2H2\\] glucose, lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA), indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation. Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D and urinary calcium excretion will also be measured.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25 and 30 kg/m2\n* Taking oral contraceptives\n* Having regular menses\n\nExclusion Criteria:\n\n* Pregnant\n* History of metabolic bone, renal or thyroid disease,\n* History of diabetes mellitus, or gestational diabetes mellitus\n* Cigarette smoking\n* Self-administration of calcium supplements\n* Regular aerobic activity, i.e. jogging \\> 1 mile/day'}, 'identificationModule': {'nctId': 'NCT00686192', 'briefTitle': 'Calcium and Lipid Metabolism', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'The Effects of Calcium Supplementation on Adipocyte Metabolism in Overweight Women', 'orgStudyIdInfo': {'id': 'WHNRC001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calcium Carbonate', 'type': 'DIETARY_SUPPLEMENT', 'description': '1500 mg per day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Janet C King, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'San Francisco General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Janet C. King, PhD', 'oldOrganization': "Children's Hospital Oakland Research Institute"}}}}