Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-25 @ 4:25 PM
Study NCT ID:
NCT05589350
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-fat Yogurt and Plasma Lipids Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2022-10-15', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory markers', 'timeFrame': '4 weeks', 'description': 'Plasma concentrations of c-reactive protein and interleukin 6'}], 'primaryOutcomes': [{'measure': 'Plasma lipid profile', 'timeFrame': '4 weeks', 'description': 'Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride'}], 'secondaryOutcomes': [{'measure': 'Glycemic measures', 'timeFrame': '4 weeks', 'description': 'Fasting plasma concentrations of glucose and insulin'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plasma Lipid Profile']}, 'referencesModule': {'references': [{'pmid': '38367032', 'type': 'DERIVED', 'citation': 'Ranjbar YR, Nasrollahzadeh J. Comparison of the impact of saturated fat from full-fat yogurt or low-fat yogurt and butter on cardiometabolic factors: a randomized cross-over trial. Eur J Nutr. 2024 Jun;63(4):1213-1224. doi: 10.1007/s00394-024-03352-8. Epub 2024 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are:\n\n-Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? In this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications\n\nExclusion Criteria:\n\n* Taking supplements of omega-3 fatty acids, or antioxidants'}, 'identificationModule': {'nctId': 'NCT05589350', 'briefTitle': 'High-fat Yogurt and Plasma Lipids Profile', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University'}, 'officialTitle': 'Comparison of the Impact of Saturated Fat From High-fat Yogurt or Low-fat Yogurt and Butter on Cardiometabolic Risk Markers: a Randomized Cross-over Trial', 'orgStudyIdInfo': {'id': '32333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-fat yogurt', 'description': 'Daily consumption of 1-2 servings (based on daily calorie requirement) of high-fat yogurt', 'interventionNames': ['Other: saturated fat intake']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-fat yogurt and butter', 'description': 'Daily consumption of 1-2 servings of low-fat yogurt along with daily consumption of about 10 grams of animal butter', 'interventionNames': ['Other: saturated fat intake']}], 'interventions': [{'name': 'saturated fat intake', 'type': 'OTHER', 'description': 'Intake of saturated fat from yogurt and animal butter daily for 4-week period', 'armGroupLabels': ['High-fat yogurt', 'Low-fat yogurt and butter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19395-4741', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Javad Nasrollahzadeh', 'investigatorAffiliation': 'Shahid Beheshti University'}}}}