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临床试验/NCT00051350
NCT00051350已完成不适用

Macronutrients and Cardiovascular Risk

Johns Hopkins University0 个研究点目标入组 164 人开始时间: 2002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
164

研究概览

简要总结

To compare the effects on blood pressure and plasma lipids of three different diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.

详细描述

BACKGROUND:

While there is widespread consensus that the optimal diet to reduce cardiovascular risk should be low in saturated fat, the type of macronutrient that should replace saturated fat (carbohydrate, protein or unsaturated fat) is a major, unresolved research question with substantial public health implications. The study will evaluate these three dietary approaches by studying their effects on established coronary risk factors and a selected group of emerging risk factors.

DESIGN NARRATIVE:

The study design was a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of a carbohydrate-rich diet patterned after the DASH diet (CARB) to two other diets, one rich in protein (PROTEIN) and another rich in unsaturated (UNSAT) fat, predominantly monounsaturated fat. The DASH diet has been shown to reduce blood pressure and LDL-cholesterol substantially, and is currently recommended by policy makers. During a one week run-in, all participants were fed samples of the three study diets (CARB, PROTEIN and UNSAT). Using a three period cross-over design, participants were then randomly assigned to the CARB, PROTEIN or UNSAT diet. Each feeding period lasted six weeks; a washout period of at least two weeks separated each feeding period. Throughout feeding (run-in and the three intervention periods), participants were fed sufficient calories to maintain their weight. Trial participants were 30 years of age or older, with systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 90-99 mmHg. Primary outcomes variables were blood pressure and the established plasma lipid risk factors (LDL-C, HDL-C and triglycerides). Secondary outcomes include total cholesterol, apolipoproteins VLDL-apoB, VLDL-apoCIII, apolipoprotein B, non-HDL cholesterol, and lipoprotein(a).

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
Single (Outcomes Assessor)

盲法说明

Outcome assessors were unaware of diet sequence.

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

CARB

Placebo Comparator

Diet rich in carbohydrate

干预措施: CARB (Other)

UNSAT

Active Comparator

Diet rich in unsaturated fat

干预措施: CARB (Other)

PROTEIN

Active Comparator

Diet rich in protein

干预措施: CARB (Other)

研究者

申办方类型
Other
责任方
Sponsor

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