An interventional study of Dietary Intervention in Cardiovascular Disease, Dyslipidemia and Inflammation, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 53 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Intervention: 3 wks of a typical Western Diet
Other: Dietary Intervention
Dietary Intervention: 3 wks of a Mediterranean-style diet
Other: Dietary Intervention
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.
Plasma LDL-cholesterol
Time frame: 3 weeks
Plasma Apolipoprotein B
Time frame: 3 weeks
Plasma Small LDL concentrations
Time frame: 3 weeks
Plasma Large LDL particle concentrations
Time frame: 3 weeks
Plasma Total LDL particle concentrations
Time frame: 3 weeks
Plasma triglycerides
Time frame: 3 weeks
Plasma HDL-cholesterol
Time frame: 3 weeks
Plasma apolipoprotein AI
Time frame: 3 weeks
Plasma oxidized LDL
Time frame: 3 weeks
Plasma C-reactive protein
Time frame: 3 weeks
Plasma Interleukin-6
Time frame: 3 weeks
Plasma Intercellular Adhesion Molecule 1 (ICAM-1)
Time frame: 3 weeks
Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time frame: 3 weeks
RH-PAT index (endothelial function)
Endothelial function measured by finger reactive hyperemia peripheral arterial tonography
Time frame: 3 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland