The Mediterranean Full-Fat Dairy Study

NCT ID: NCT02781675

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-06-30

Brief Summary

A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts, moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive oil as the main source of fat has been associated with reduced risk of cardiovascular disease (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory Committee. The strongest experimental support for this recommendation derives from the success of the recent PREDIMED CVD outcomes trial, and studies indicating that a Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease risk in comparison to either low-fat or Western dietary patterns. However, in none of these studies were comparisons made between the effects of Mediterranean-style diets with low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a Mediterranean dietary pattern based on that used in the PREDIMED study results in similar improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2) modification of the Mediterranean diet by replacing low-fat dairy products with high-fat dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase LDL-C and apoB but may raise large buoyant LDL particles compared with a standard Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in endothelial function compared to a Western diet.

Conditions

Cardiovascular Disease; Dyslipidemia; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Western Diet

Dietary Intervention: 3 wks of a typical Western Diet

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: OTHER

3 wk dietary intervention with prescribed menus and \~50% foods provided.

Mediterranean Diet

Dietary Intervention: 3 wks of a Mediterranean-style diet

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: OTHER

3 wk dietary intervention with prescribed menus and \~50% foods provided.

Modified Mediterranean Diet

Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: OTHER

3 wk dietary intervention with prescribed menus and \~50% foods provided.

Interventions

Dietary Intervention

3 wk dietary intervention with prescribed menus and \~50% foods provided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI 25-35 kg/m2
• Weight stable for > 3 months
• Agrees to abstain from alcohol or dietary supplements during the study

Exclusion Criteria

• History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
• Current use of hormones or drugs knowns to affect lipid metabolism
• Use of nicotine products or recreational drugs
• Abnormal TSH
• Pregnant or breastfeeding
• Total- and LDL- cholesterol > 95th percentile for sex and age
• Fasting triglyceride > 500 mg/dl
• Fasting blood sugar > 126 mg/dl
• Blood pressure >160/95 mm Hg
• Allergy to or unwillingness to consume study foods

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dairy Management Inc.

INDUSTRY

Sponsor Role: collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald M Krauss, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

Cholesterol Research Center

Berkeley, California, United States

Countries

United States

Other Identifiers

2016-012

Identifier Type: -

Identifier Source: org_study_id