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临床试验/NCT00895141
NCT00895141已完成不适用

Changes in LDL and HDL With Increased Intake of Saturated Fat From Dairy Foods in Individuals With Atherogenic Dyslipidemia and LDL Subclass Pattern B

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2009年4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
53
试验地点
2
主要终点
Large LDL (LDL I + 2a) (mg/dl)

研究概览

简要总结

The purpose of the study is to test whether increased saturated fat intake results in increased levels of larger LDL and HDL particles in individuals with LDL Pattern B.

详细描述

Increased saturated fat intake is known to elevate plasma levels of both low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), however, less is know regarding the effect of saturated fat on lipoprotein subclasses. We previously showed that, in the context of a reduced carbohydrate diet, saturated fat induced increases in LDL cholesterol were apparently due to increases in large, more buoyant LDL without increases in small, dense LDL. This finding was supported by a previous dietary intervention study showing a correlation between saturated fat intake and large LDL. In both cases, this increase in large LDL was correlated with an increase in large HDL. In this study, we will test the following specific hypotheses regarding changes in plasma lipoproteins induced by a diet high in myristic acid and other saturated fats derived primarily from dairy sources in individuals with LDL subclass pattern B: 1) there will be a coordinate increase in levels of large HDL particles that are considered anti-atherogenic and large LDL particles that are less strongly associated with increased CVD risk than smaller LDL; 2) this change in lipoprotein profile will result in a higher proportion of pattern B individuals converting to LDL subclass pattern A (predominance of larger LDL); and 3) the coordinate increase in large HDL and LDL is due to a common underlying pathway. The latter hypothesis will be addressed by assaying cholesterol ester transfer protein (CETP), hepatic lipase (HL), and lipoprotein lipase (LPL).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or postmenopausal woman between 18-70 yrs
  • Body Mass Index between 25-35
  • Blood pressure <150/90
  • Non smoking
  • Agrees to consume no alcohol or dietary supplements during the study
  • LDL Subclass Pattern B
  • Total cholesterol and LDLC ≤95th percentile for sex and age
  • Fasting triglycerides ≤ 500mg/dl
  • Fasting blood sugar < 126 mg/dl
  • At least 3 months weight stable

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) in the last 5 years
  • Taking drugs known to affect lipid metabolism or hormones
  • Abnormal thyroid stimulating hormone (TSH)

结局指标

主要结局

Large LDL (LDL I + 2a) (mg/dl)

时间窗: 3 wk, 6 wk

Large HDL (HDL2b) (mg/dl)

时间窗: 3 wk, 6 wk

LDL peak particle size

时间窗: 3 wk, 6 wk

次要结局

  • Triglycerides (mg/dl)(3 wk, 6 wk)
  • Total Cholesterol (mg/dl)(3 wk, 6 wk)
  • LDL cholesterol (mg/dl)(3 wk, 6 wk)
  • HDL cholesterol (mg/dl)(3 wk, 6 wk)
  • Apolipoprotein AI (mg/dl)(3 wk, 6 wk)
  • Apolipoprotein B (mg/dl)(3 wk, 6 wk)
  • Medium LDL (LDL2b) (mg/dl)(3 wk, 6 wk)
  • Small LDL (LDL3a) (mg/dl)(3 wk, 6 wk)
  • Hepatic Lipase Activity(3 wk, 6 wk)
  • Lipoprotein Lipase Activity(3 wk, 6 wk)
  • Cholesteryl Ester Transfer Protein Activity(3 wk, 6 wk)
  • Very Small LDL (LDL3b, 4a, 4b) (mg/dl)(3 wk, 6 wk)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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