Clinical trial NCT02781675: The Mediterranean Full-Fat Dairy Study
Official title: Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Dyslipidemia
Inflammation
Keywords: Diet
Mediterranean
Cholesterol
Inflammation
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2016-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Plasma LDL-cholesterol
timeFrame: 3 weeks
measure: Plasma Apolipoprotein B
timeFrame: 3 weeks
measure: Plasma Small LDL concentrations
timeFrame: 3 weeks
measure: Plasma Large LDL particle concentrations
timeFrame: 3 weeks
measure: Plasma Total LDL particle concentrations
timeFrame: 3 weeks
Secondary outcomes:
measure: Plasma triglycerides
timeFrame: 3 weeks
measure: Plasma HDL-cholesterol
timeFrame: 3 weeks
measure: Plasma apolipoprotein AI
timeFrame: 3 weeks
measure: Plasma oxidized LDL
timeFrame: 3 weeks
measure: Plasma C-reactive protein
timeFrame: 3 weeks
measure: Plasma Interleukin-6
timeFrame: 3 weeks
measure: Plasma Intercellular Adhesion Molecule 1 (ICAM-1)
timeFrame: 3 weeks
measure: Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)
timeFrame: 3 weeks
measure: RH-PAT index (endothelial function)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Cholesterol Research Center
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Ronald M Krauss, MD
role: PRINCIPAL_INVESTIGATOR
References: