The Mediterranean Full-Fat Dairy Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Dyslipidemia, Cardiovascular Disease, Inflammation

Intervention / Treatment
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* Other: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Mediterranean, Cholesterol, Inflammation