Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00942656
Status:
COMPLETED
Last Update Posted:
2011-02-09
First Post:
2009-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000468', 'term': 'Alkalies'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-08', 'studyFirstSubmitDate': '2009-07-17', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL cholesterol', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['trans fatty acids', 'ruminant', 'cardiovascular disease'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '26561632', 'type': 'DERIVED', 'citation': 'Gebauer SK, Destaillats F, Dionisi F, Krauss RM, Baer DJ. Vaccenic acid and trans fatty acid isomers from partially hydrogenated oil both adversely affect LDL cholesterol: a double-blind, randomized controlled trial. Am J Clin Nutr. 2015 Dec;102(6):1339-46. doi: 10.3945/ajcn.115.116129. Epub 2015 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11 conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL cholesterol compared to a low trans fatty acid diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 20 and 38 kg/m2\n* Age 25 to 65 years during the intervention\n* Fasting glucose \\< 126 mg/dl\n* Blood pressure \\< 160/100 mm Hg (controlled with certain medications)\n* Total plasma cholesterol \\< 280 mg/dl\n* Fasting triglycerides \\< 300 mg/dl\n\nExclusion Criteria:\n\n* Use of prescription or over-the-counter medications or supplements that alter lipid metabolism.\n* History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.\n* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.\n* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).\n* Women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women.\n* Volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.\n* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months.\n* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.\n* Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).\n* Smokers or other tobacco users (during the 6 months prior to the start of the study).\n* Unable or unwilling to give informed consent or communicate with study staff.\n* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).\n* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.'}, 'identificationModule': {'nctId': 'NCT00942656', 'briefTitle': 'Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease', 'organization': {'class': 'FED', 'fullName': 'USDA Beltsville Human Nutrition Research Center'}, 'officialTitle': 'Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease', 'orgStudyIdInfo': {'id': '2006-293'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PHVO', 'type': 'OTHER', 'description': 'base diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil'}, {'name': 'CLA', 'type': 'OTHER', 'description': 'base diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid'}, {'name': 'VA', 'type': 'OTHER', 'description': 'base diet plus 3.0% energy added from vaccenic acid'}, {'name': 'base', 'type': 'OTHER', 'description': 'base diet containing approximately 0.1% energy of mixed trans fatty acid isomers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20705', 'city': 'Beltsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'USDA-ARS, Beltsville Human Nutrition Research Center', 'geoPoint': {'lat': 39.03483, 'lon': -76.90747}}], 'overallOfficials': [{'name': 'David J Baer, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Department of Agriculture (USDA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Department of Agriculture (USDA)', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'David J. Baer, Ph. D., Principal Investigator', 'oldOrganization': 'USDA-ARS'}}}}