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| Name | Class |
|---|---|
| Dairy Management Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western Diet | Experimental | Dietary Intervention: 3 wks of a typical Western Diet |
|
| Mediterranean Diet | Experimental | Dietary Intervention: 3 wks of a Mediterranean-style diet |
|
| Modified Mediterranean Diet | Experimental | Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Other | 3 wk dietary intervention with prescribed menus and ~50% foods provided. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma triglycerides | 3 weeks | |
| Plasma HDL-cholesterol | 3 weeks | |
| Plasma apolipoprotein AI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald M Krauss, MD | UCSF Benioff Children's Hospital Oakland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cholesterol Research Center | Berkeley | California | 94705 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |