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临床试验/NCT01404897
NCT01404897已完成不适用

Effects of a Modified Lower Carbohydrate, Higher Fat DASH Diet Plan on Plasma Lipids, Lipoprotein Particle Size, and Blood Pressure in Healthy Adults

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Small LDL particles

研究概览

简要总结

The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk, namely HDL-cholesterol and triglycerides. The overall objective of this study is to determine whether modification of the DASH diet by substituting carbohydrate with fat will result in improvements in multiple biomarkers of CVD risk. Specifically, the investigators will test the hypotheses that modification of the DASH diet by reducing carbohydrate, primarily in the form of simple sugars and glycemic starches, and allowing for a more liberal intake of total and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of CVD risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL particles, and increased HDL-C, apoAI, and large HDL particles); and (2) result in comparable reductions of systolic and diastolic blood pressure to those achieved with the standard DASH diet. The investigators will also assess the effects of the modified DASH diet on markers of insulin resistance and inflammation. Our main hypotheses will be tested by a controlled dietary intervention conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks each, a control Western diet, a standard DASH diet, and a modified low-carbohydrate DASH diet, separated by 2-week washout periods.

研究设计

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

入排标准

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

入选标准

  • Age 22 years and older
  • Average systolic blood pressure <160 mm Hg and diastolic blood pressure 80 - 95 mm Hg measured on 2 separate days
  • Non-smoking
  • Agrees to abstain from alcohol and dietary supplements during the study
  • Willing to consume all study foods as instructed

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.
  • Taking hormones or drugs known to affect lipid metabolism or blood pressure.
  • Body Mass Index (BMI) > 35
  • Total- and LDL-cholesterol > 95th percentile for sex and age.
  • Fasting triglycerides > 500 mg/dl.
  • Fasting blood sugar (FBS) > 126 mg/dl.
  • Abnormal thyroid stimulating hormone
  • Not weight stable
  • Pregnant or breast-feeding

结局指标

主要结局

Small LDL particles

时间窗: 14 weeks

Large HDL particles

时间窗: 14 weeks

Total:HDL-cholesterol ratio

时间窗: 14 weeks

HDL-cholesterol

时间窗: 14 weeks

Apolipoprotein B

时间窗: 14 weeks

Apolipoprotein AI

时间窗: 14 weeks

次要结局

  • Lipoprotein Subclasses (HDL, LDL, IDL, VLDL)(End of each experimental diet (4 wks, 9 wks, and 14 wks))
  • Blood Pressure(End of each experimental diet (4 wks, 9 wks, and 14 wks))
  • Total Cholesterol(End of each experimental diet (4 wks, 9 wks, and 14 wks))
  • LDL-Cholesterol(End of each experimental diet (4 wks, 9 wks, and 14 wks))
  • Triglycerides(End of each experimental diet (4 wks, 9 wks, and 14 wks))
  • HOMA-IR(End of each experimental diet (4 wks, 9 wks, and 14 wks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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