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临床试验/NCT01427855
NCT01427855已完成不适用

Saturated Fat and Protein Effects on Atherogenic Dyslipidemia

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2012年1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
113
试验地点
2
主要终点
Change from baseline in LDL-Cholesterol

研究概览

简要总结

There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake.

The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.

详细描述

Clinic Visits:

Participants will visit the clinic a total of 11 times from screen to completion of study. This will include weekly visits with the nutritionist and 9 visits requiring blood draws (at screen and on 2 consecutive visits after each dietary period). At each visit, participants will be weighed, waist and hip circumference will be measured and blood pressure will be monitored. The total amount of blood collected during the course of the study will be 455 mL.

Screening visit (SV: 1 hour):

Recruiters will initially determine eligibility through review of a screening questionnaire and a telephone or personal interview. If a potential subject is eligible and interested, an orientation package will be mailed that will include written information about the study requirements. Interested individuals passing pre-screening will be scheduled for a screening blood draw visit to determine final eligibility. At the screening visit (SV), participants will give informed consent, review their medical history with a registered nurse, and have their blood pressure, weight, height, and waist and hip circumference measured. Thirty ml of blood will be drawn for measurement of plasma triglycerides (TG), total-C, LDL-C, HDL-C, glucose and thyroid stimulating hormone (TSH). Women of childbearing potential will be given a beta-Human Chorionic Gonadotropin (b-hCG) urine pregnancy test. Participants will be contacted within 2 weeks to notify them of their eligibility.

Nutritionist Visits (Initial: 1 hr):

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
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30-65 years old
  • 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 heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, lung disease, diabetes, Human immunodeficiency virus (HIV), or cancer (other than skin cancer) in the last 5 years
  • Body mass index (BMI) > 35 kg/m2 or < 20 kg/m2
  • Not weight stable
  • Abnormal thyroid stimulating hormone
  • Blood pressure > 150/90
  • Fasting blood sugar >126 mg/dl
  • Fasting triglyceride levels >500 mg/dl
  • Total- and LDL cholesterol >95th percentile for age and sex
  • Pregnant or breastfeeding
  • Taking hormones or drugs known to affect lipid metabolism

结局指标

主要结局

Change from baseline in LDL-Cholesterol

时间窗: 6 weeks, 12 weeks, 18 weeks

Change from baseline in ApoB

时间窗: 6 weeks, 12 weeks, 18 weeks

Change from baseline in Small + Medium Sized LDL

时间窗: 6 weeks, 12 weeks, 18 weeks

Change from baseline in Total Cholesterol/HDL Cholesterol ratio

时间窗: 6 weeks, 12 weeks, 18 weeks

次要结局

  • Change from baseline in apoAI(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in HDL-Cholesterol(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in non-HDLC(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in apoAII(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in HDL3 Cholesterol(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR)(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in C-Reactive Protein(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in Tumor Necrosis Factor-alpha(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in Interleukin-6(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in Monocyte Chemotactic Protein-1 (MCP-1)(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in RH-PAT index(6 weeks, 12 weeks, 18 weeks)
  • Change from baseline in HDL2 Cholesterol(6 weeks, 12 weeks, 18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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