Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-02 @ 1:57 AM
Study NCT ID:
NCT00852267
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2009-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2009-02-24', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Cholesterol', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}, {'measure': 'Non-HDL Cholesterol', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}, {'measure': 'Apolipoprotein B', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}, {'measure': 'LDL-Cholesterol/HDL-Cholesterol', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}, {'measure': 'Apolipoprotein B/Apolipoprotein AI', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}], 'secondaryOutcomes': [{'measure': 'LDL peak diameter', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}, {'measure': 'LDL subclass 3 (LDL3)', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}, {'measure': 'HDL subclass 2 (HDL2)', 'timeFrame': '3 weeks, 8 weeks, and 13 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cholesterol', 'diet', 'protein', 'carbohydrate', 'saturated fat', 'LDL subclass', 'healthy volunteers'], 'conditions': ['Healthy', 'Cardiovascular Disease', 'Atherogenic Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '22031660', 'type': 'DERIVED', 'citation': 'Mangravite LM, Chiu S, Wojnoonski K, Rawlings RS, Bergeron N, Krauss RM. Changes in atherogenic dyslipidemia induced by carbohydrate restriction in men are dependent on dietary protein source. J Nutr. 2011 Dec;141(12):2180-5. doi: 10.3945/jn.111.139477. Epub 2011 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will improve risk factors for cardiovascular disease.', 'detailedDescription': 'The primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blood pressure less than 150/90\n* Body mass index (BMI)≥ 20 and ≤ 35 kg/m2\n* Non-smoker\n* Agrees not to consume alcohol during the study\n* Agrees to abstain from taking dietary supplements during the study\n* LDL-cholesterol and total cholesterol \\< 95th percentile for age and sex\n* Fasting triglycerides \\< 500 mg/dL\n* Fasting glucose concentration \\< 126 mg/dL\n* Hematocrit (HCT) ≥ 36%\n* At least three months of a weight-stable state (± 3% of body weight)\n\nExclusion Criteria:\n\n* Personal history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, diabetes, lung disease, bleeding disorder, liver or renal disease, HIV or of cancer (other than skin cancer) in the last five years\n* Taking drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent warfarin\n* Abnormal thyroid stimulating hormone (TSH)\n* Strength trains with resistance weights more than four hours per week'}, 'identificationModule': {'nctId': 'NCT00852267', 'briefTitle': 'Lipoprotein Effects of Substituting Beef Protein for Carbohydrate', 'organization': {'class': 'OTHER', 'fullName': "UCSF Benioff Children's Hospital Oakland"}, 'officialTitle': 'Lipoprotein Effects of Substituting Beef Protein for Carbohydrate', 'orgStudyIdInfo': {'id': '2007-068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High CHO, High SatFat Diet', 'interventionNames': ['Other: High Carbohydrate, High Saturated Fat Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low CHO, High SatFat Diet', 'interventionNames': ['Other: Low Carbohydrate, High Saturated Fat Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low CHO, Low SatFat Diet', 'interventionNames': ['Other: Low Carbohydrate, Low Saturated Fat Diet']}], 'interventions': [{'name': 'High Carbohydrate, High Saturated Fat Diet', 'type': 'OTHER', 'description': '50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)', 'armGroupLabels': ['High CHO, High SatFat Diet']}, {'name': 'Low Carbohydrate, High Saturated Fat Diet', 'type': 'OTHER', 'description': '31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)', 'armGroupLabels': ['Low CHO, High SatFat Diet']}, {'name': 'Low Carbohydrate, Low Saturated Fat Diet', 'type': 'OTHER', 'description': '31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)', 'armGroupLabels': ['Low CHO, Low SatFat Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Cholesterol Research Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Ronald M Krauss, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, 'collaborators': [{'name': "National Cattlemen's Beef Association, a contractor to the Beef Checkoff", 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}