The Mediterranean Full-Fat Dairy Study (MFFD)

Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Cardiovascular Disease; Dyslipidemia
• Intervention / Treatment: Other: Dietary Intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94705
      • Cholesterol Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Western Diet; Dietary Intervention: 3 wks of a typical Western Diet	Other: Dietary Intervention; 3 wk dietary intervention with prescribed menus and ~50% foods provided.
Experimental: Mediterranean Diet; Dietary Intervention: 3 wks of a Mediterranean-style diet	Other: Dietary Intervention; 3 wk dietary intervention with prescribed menus and ~50% foods provided.
Experimental: Modified Mediterranean Diet; Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products	Other: Dietary Intervention; 3 wk dietary intervention with prescribed menus and ~50% foods provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma LDL-cholesterol	3 weeks
Plasma Apolipoprotein B	3 weeks
Plasma Small LDL concentrations	3 weeks
Plasma Large LDL particle concentrations	3 weeks
Plasma Total LDL particle concentrations	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma triglycerides		3 weeks
Plasma HDL-cholesterol		3 weeks
Plasma apolipoprotein AI		3 weeks
Plasma oxidized LDL		3 weeks
Plasma C-reactive protein		3 weeks
Plasma Interleukin-6		3 weeks
Plasma Intercellular Adhesion Molecule 1 (ICAM-1)		3 weeks
Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)		3 weeks
RH-PAT index (endothelial function)	Endothelial function measured by finger reactive hyperemia peripheral arterial tonography	3 weeks

Collaborators and Investigators

• Sponsor: UCSF Benioff Children's Hospital Oakland
• Collaborators: Dairy Management Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimate): May 24, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Cholesterol; Diet; Mediterranean
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Lipid Metabolism Disorders; Cardiovascular Diseases; Inflammation; Dyslipidemias
• Other Study ID Numbers: 2016-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO