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Effects of Almond Intake on Atherogenic Lipoprotein Particles

2017年10月31日 更新者:UCSF Benioff Children's Hospital Oakland

Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity

Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches.

Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses.

The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended.

This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference).

We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with increased abdominal adiposity. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.

研究概览

研究类型

介入性

注册 (实际的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Berkeley、California、美国、94705
        • Cholesterol Research Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 20 or older
  • Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
  • Fasting blood sugar (FBS) < 126 mg/dl
  • Weight stable for > 3 months.

Exclusion Criteria:

  • 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.
  • Systolic blood pressure > 160 mm Hg and diastolic blood pressure > 95 mm Hg.
  • Body mass index (BMI) > 38 kg/m2
  • User of nicotine products or recreational drugs
  • Refusal to abstain from alcohol or dietary supplements during the study.
  • Total- and LDL-C > 95th percentile for sex and age.
  • Fasting triglycerides > 50mg/dl and > 500 mg/dl
  • Abnormal thyroid stimulating hormone (TSH) levels.
  • Pregnant or breast-feeding

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Standard Reference Diet
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
实验性的:Almond Supplemented Diet
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
有源比较器:Low Carbohydrate Reference Diet
26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Total and LDL cholesterol
大体时间:3 weeks, 8 weeks, 13 weeks
Change in total and LDL cholesterol between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in small and medium LDL particles
大体时间:3 weeks, 8 weeks, and 13 weeks
Change in small and medium LDL particles between each of the 3 test diets
3 weeks, 8 weeks, and 13 weeks
Change in apolipoprotein B
大体时间:3 weeks, 8 week, 13 weeks
Change in apolipoprotein B between each of the 3 test diets
3 weeks, 8 week, 13 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in total/HDL-cholesterol ratio
大体时间:3 weeks, 8 weeks, 13 weeks
Change in total/HDL-cholesterol ratio between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in LDL peak particle diameter
大体时间:3 weeks, 8 week, 13 weeks
Change in LDL peak particle diameter between each of the 3 test diets
3 weeks, 8 week, 13 weeks
Change in plasma triglycerides
大体时间:3 weeks, 8 weeks, 13 weeks
Change in plasma triglycerides between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in HDL-cholesterol
大体时间:3 weeks, 8 weeks, 13 weeks
Change in HDL-cholesterol between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in large HDL particles
大体时间:3 weeks, 8 weeks, 13 weeks
Change in large HDL particles between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in apolipoprotein AI
大体时间:3 weeks, 8 weeks, 13 weeks
Change in apolipoprotein AI between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in HOMA-IR
大体时间:3 weeks, 8 weeks, 13 weeks
Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets
3 weeks, 8 weeks, 13 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (实际的)

2016年2月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2012年4月26日

首先提交符合 QC 标准的

2013年2月13日

首次发布 (估计)

2013年2月15日

研究记录更新

最后更新发布 (实际的)

2017年11月6日

上次提交的符合 QC 标准的更新

2017年10月31日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Standard reference diet的临床试验

3
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