High-fat Yogurt and Plasma Lipids Profile

• Sponsor: Shahid Beheshti University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05589350
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plasma Lipid Profile	Other: saturated fat intake	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Oct 15, 2022
• Anticipated Primary Completion Date: Feb 15, 2023
• Anticipated Study Completion Date: Feb 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma lipid profile [4 weeks]

   Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride

Secondary Outcome Measures

1. Glycemic measures [4 weeks]

   Fasting plasma concentrations of glucose and insulin

Other Outcome Measures

1. Inflammatory markers [4 weeks]

   Plasma concentrations of c-reactive protein and interleukin 6

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute	Tehran		Iran, Islamic Republic of	19395-4741

Sponsors and Collaborators

• Shahid Beheshti University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Javad Nasrollahzadeh, Associate Professor, Shahid Beheshti University
• ClinicalTrials.gov Identifier: NCT05589350
• Other Study ID Numbers: 32333
• First Posted: Oct 21, 2022
• Last Update Posted: Jan 5, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 5, 2023