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临床试验/NCT02781675
NCT02781675已完成不适用

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

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Plasma Small LDL concentrations

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 25-35 kg/m2
  • Weight stable for > 3 months
  • Agrees to abstain from alcohol or dietary supplements during the study

排除标准

  • 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

研究组 & 干预措施

Western Diet

Experimental

Dietary Intervention: 3 wks of a typical Western Diet

干预措施: Dietary Intervention (Other)

Mediterranean Diet

Experimental

Dietary Intervention: 3 wks of a Mediterranean-style diet

干预措施: Dietary Intervention (Other)

Modified Mediterranean Diet

Experimental

Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products

干预措施: Dietary Intervention (Other)

结局指标

主要结局

Plasma Small LDL concentrations

时间窗: 3 weeks

Plasma Total LDL particle concentrations

时间窗: 3 weeks

Plasma LDL-cholesterol

时间窗: 3 weeks

Plasma Apolipoprotein B

时间窗: 3 weeks

Plasma Large LDL particle concentrations

时间窗: 3 weeks

次要结局

  • Plasma triglycerides(3 weeks)
  • Plasma apolipoprotein AI(3 weeks)
  • Plasma oxidized LDL(3 weeks)
  • Plasma HDL-cholesterol(3 weeks)
  • Plasma Interleukin-6(3 weeks)
  • Plasma Intercellular Adhesion Molecule 1 (ICAM-1)(3 weeks)
  • Plasma C-reactive protein(3 weeks)
  • Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)(3 weeks)
  • RH-PAT index (endothelial function)(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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