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Effect of Dietary Macronutrient Composition

2019年2月4日 更新者:Elizabeth Parks、University of Texas Southwestern Medical Center

Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism

The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.

研究概览

详细说明

Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US. However, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. Here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. The investigators hypothesize that Hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to African American subjects.

Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid metabolism will be measured in the liver and periphery. This will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. Subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months.

The specific aims are as follows:

AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and African Americans with metabolic syndrome.

Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to African Americans.

AIM 2: Determine the effects of low-CHO and low-fat diets on liver fat regression.

Hypothesis: Compared to a low-fat diet, a low-CHO diet will markedly decrease markers of inflammation coincident with greater improvements in insulin sensitivity as assessed by an intravenous glucose tolerance test.

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

    • Texas
      • Dallas、Texas、美国、75390-9052
        • Center for Human Nutrition

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 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Elevated serum ALT or metabolic syndrome
  • African American or Hispanic
  • Nondiabetic
  • Men or women
  • Smokers and nonsmokers
  • Pre- and post-menopausal (+/- HRT)
  • Stable body weight
  • Age 20-65 years
  • BMI between 25-45 kg/m2

Exclusion Criteria:

  • Diabetes or Pregnancy
  • Ethanol intake: males > 140 g/week, females > 70 g/week
  • Chronic hepatitis B or chronic hepatitis C
  • Hemochromatosis or Wilson's Disease
  • Autoimmune hepatitis or primary biliary cirrhosis

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:基础科学
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Hispanic subjects
Subjects will identify as Hispanic ethnicity.
The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.
The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.
其他:African American subjects
Subjects will self-identify as African American in origin.
The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.
The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.

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
de novo lipogenesis
大体时间:Change from Baseline in fatty acid synthesis at 5 months
In vivo measurement is made of liver fatty acid synthesis using stable isotope administration and analysis of plasma samples by GS/MS
Change from Baseline in fatty acid synthesis at 5 months

次要结果测量

结果测量
措施说明
大体时间
Dietary fatty acid clearance to liver
大体时间:Change from Baseline in dietary fat clearance at 5 months
Using a dietary stable isotope we will quantitate fat absorption and recycling of fat through the liver.
Change from Baseline in dietary fat clearance at 5 months
Adipose fatty acid flux
大体时间:Change from Baseline in adipose fat flux at 5 months
A stable isotope is infused and the rate of adipose fatty acid release is calculated after analyzing blood samples.
Change from Baseline in adipose fat flux at 5 months

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。

调查人员

  • 首席研究员:Elizabeth J Parks, PhD、UTSW Medical Center

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。

一般刊物

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 (实际的)

2007年9月1日

初级完成 (实际的)

2013年12月31日

研究完成 (实际的)

2013年12月31日

研究注册日期

首次提交

2011年6月7日

首先提交符合 QC 标准的

2011年6月9日

首次发布 (估计)

2011年6月10日

研究记录更新

最后更新发布 (实际的)

2019年2月6日

上次提交的符合 QC 标准的更新

2019年2月4日

最后验证

2019年2月1日

更多信息

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.

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