High-fat Yogurt and Plasma Lipids Profile
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
1 other identifier
interventional
30
1 country
1
Brief Summary
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2022
CompletedStudy Start
First participant enrolled
October 15, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2023
CompletedApril 18, 2023
April 1, 2023
6 months
October 15, 2022
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma lipid profile
Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride
4 weeks
Secondary Outcomes (1)
Glycemic measures
4 weeks
Other Outcomes (1)
Inflammatory markers
4 weeks
Study Arms (2)
High-fat yogurt
EXPERIMENTALDaily consumption of 1-2 servings (based on daily calorie requirement) of high-fat yogurt
Low-fat yogurt and butter
ACTIVE COMPARATORDaily consumption of 1-2 servings of low-fat yogurt along with daily consumption of about 10 grams of animal butter
Interventions
Intake of saturated fat from yogurt and animal butter daily for 4-week period
Eligibility Criteria
You may qualify if:
- Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications
You may not qualify if:
- Taking supplements of omega-3 fatty acids, or antioxidants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, 19395-4741, Iran
Related Publications (1)
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.
PMID: 38367032DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 15, 2022
First Posted
October 21, 2022
Study Start
October 15, 2022
Primary Completion
April 13, 2023
Study Completion
April 13, 2023
Last Updated
April 18, 2023
Record last verified: 2023-04