Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04120220
Status:
TERMINATED
Last Update Posted:
2022-08-04
First Post:
2019-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shake It Up: Lipidomics of Lipoproteins and Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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': 'D013024', 'term': 'Soybean Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-23', 'size': 293423, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-05-24T10:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'PI will be retiring from the Center. Research will not continue with a new PI.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)', 'timeFrame': '0, 1, 2, 4, 6, 8 hours post meal intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Normal weight'], 'conditions': ['Overweight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/', 'label': 'Grand Forks Human Nutrition Research Center Current Nutrition Studies'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. The researchers want to know if these particles change after eating meals made with different fats.', 'detailedDescription': 'The overall objective of this work is to discover how the lipidomic composition of postprandial lipoproteins responds to dietary fats of differing fatty acid composition by comparing meals rich in saturated fatty acid (SFA) (from dairy cream) versus polyunsaturated fatty acids (PUFA) (from soybean oil). The information derived from these studies will provide mechanistic insight into postprandial lipid metabolism and will support efforts to identify optimal dietary oil intakes for people.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal to overweight (BMI 18.0-29.9 kg/m\\^2\n* Willing to comply with the demands of the experimental protocol\n\nExclusion Criteria:\n\n* Inability to provide consent\n* Have fasting blood glucose \\<60 mg/dL or \\>126 mg/dL\n* Have fasting blood cholesterol \\>300 mg/dL\n* Have fasting blood triglyceride \\<100 mg/dL or \\>300 mg/dL\n* Have uncontrolled hypertension (blood pressure \\>140/90 mm Hg)\n* Take prescription medications for blood sugar or lipid management or anti-inflammatory steroids (e.g. cortisone)\n* Over the counter use of supplements (fish oil, flax, plant sterol or sterol esters) and unwilling to discontinue use for 6 weeks prior to study initiation\n* Have a history of an eating disorder, unusual dietary pattern (extreme nutrient or food group restriction; erratic meals due to shift work, etc.)\n* Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes\n* Have cancer\n* Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes/vaping in the past 6 weeks\n* Have alcohol, anabolic steroids, or other substance abuse issues\n* Consume more than 3 alcoholic drinks/week\n* Are lactose intolerant or have an allergy to dairy foods'}, 'identificationModule': {'nctId': 'NCT04120220', 'briefTitle': 'Shake It Up: Lipidomics of Lipoproteins and Diet', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Shake It Up: Lipidomics of Lipoproteins and Diet', 'orgStudyIdInfo': {'id': 'GFHNRC511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heavy Cream', 'description': 'Participants will receive a meal containing 30 g of fat prepared with heavy cream.', 'interventionNames': ['Other: Heavy Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Soybean Oil', 'description': 'Participants will receive a meal containing 30 g of fat prepared with soybean oil.', 'interventionNames': ['Other: Soybean Oil']}], 'interventions': [{'name': 'Heavy Cream', 'type': 'OTHER', 'description': 'Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.', 'armGroupLabels': ['Heavy Cream']}, {'name': 'Soybean Oil', 'type': 'OTHER', 'description': 'Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with soybean oil.', 'armGroupLabels': ['Soybean Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58203', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Matthew Picklo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}