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

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.

Study Overview

• Status: Completed
• Conditions: Plasma Lipid Profile
• Intervention / Treatment: Other: saturated fat intake

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19395-4741
    • Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications

Exclusion Criteria:

• Taking supplements of omega-3 fatty acids, or antioxidants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-fat yogurt; Daily consumption of 1-2 servings (based on daily calorie requirement) of high-fat yogurt	Other: saturated fat intake; Intake of saturated fat from yogurt and animal butter daily for 4-week period
Active Comparator: Low-fat yogurt and butter; Daily consumption of 1-2 servings of low-fat yogurt along with daily consumption of about 10 grams of animal butter	Other: saturated fat intake; Intake of saturated fat from yogurt and animal butter daily for 4-week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma lipid profile	Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic measures	Fasting plasma concentrations of glucose and insulin	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	Plasma concentrations of c-reactive protein and interleukin 6	4 weeks

Collaborators and Investigators

• Sponsor: Shahid Beheshti University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 32333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No