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Effects of Polyunsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin-resistant Men (PUFA)

2016年9月7日 更新者:Patrick Couture、Laval University

Differential Effects of Saturated and Polyunsaturated Fatty Acids on Chylomicron Secretion and Expression of Key Genes and Proteins That Regulate Intestinal Lipid Metabolism in Men With Dyslipidemia Associated With Insulin-resistance

The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma TRL levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by n-6 polyunsaturated fatty acids (PUFAs) reduces CVD risk in the general population. Although the beneficial impact of n-6 PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic n-6 PUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by n-6 PUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal triglyceride-rich lipoproteins (TRLs) represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary n-6 PUFAs in place of SFAs modify intestinal lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in n-6 PUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by n-6 PUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.

研究概览

研究类型

介入性

注册 (实际的)

30

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

      • Quebec、加拿大、G1V 0A6
        • Institute of Nutrition and Functional Foods (INAF)

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

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Men aged between 18-60 years
  • Waist circumference > 102 cm
  • HDL-cholesterol < 1.1 mmol/L
  • Triglycerides > 1.7 mmol/L
  • Fasting blood glucose > 6.1 mmol/L
  • Normal blood pressure (<130/85)

Exclusion Criteria:

  • Women
  • Men < 18 or > 60 years
  • Smokers (> 1 cigarette/day)
  • Body weight variation > 10% during the last 6 months prior to the study baseline
  • Subjects with a previous history of cardiovascular disease
  • Subjects with type 2 diabetes
  • Subjects with a monogenic dyslipidemia
  • Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
  • Subjects with endocrine or gastrointestinal disorders
  • History of alcohol or drug abuse within the past 2 years
  • Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

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:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Polyunsaturated fatty acids diet
During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 6.0% from saturated fat; 14.4% from monounsaturated fat; 12.6% from n-6 polyunsaturated fat).
During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 6.0% from saturated fat; 14.4% from monounsaturated fat; 12.6% from n-6 polyunsaturated fat).
实验性的:Saturated fatty acids diet
During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 13.4% from saturated fat; 15.3% from monounsaturated fat; 4.0% from n-6 polyunsaturated fat).
During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 13.4% from saturated fat; 15.3% from monounsaturated fat; 4.0% from n-6 polyunsaturated fat).

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in TRL apolipoprotein B48 (apoB-48) production rate.
大体时间:At week 4 and week 12 (at the end of the two 4-weeks diets).
At week 4 and week 12 (at the end of the two 4-weeks diets).

次要结果测量

结果测量
措施说明
大体时间
Changes in duodenal expression of genes that regulate intestinal lipid absorption.
大体时间:At week 4 and week 12 (at the end of the two 4-weeks diets).
Genes that regulate intestinal lipid absorption that will be measured are Niemann-Pick C1-like 1 (NPC1L1), Adenosine triphosphate(ATP)-binding cassette transporters (ABCG5/8), Fatty Acid Binding Protein (FABP), Sterol Regulatory Element Binding Protein (SREBP-1c).
At week 4 and week 12 (at the end of the two 4-weeks diets).
Changes in duodenal expression of genes that regulate intestinal lipid synthesis.
大体时间:At week 4 and week 12 (at the end of the two 4-weeks diets).
Genes that regulate intestinal lipid synthesis that will be measured are Acyl-Coenzyme A(CoA):diacylglycerol acyltransferase (DGAT), Acyl-CoA:cholesterol O-acyltransferase 2 (ACAT2) and 3-hydroxy-methylglutaryl-CoA reductase (HMG CoA reductase).
At week 4 and week 12 (at the end of the two 4-weeks diets).
Change in synthesis of apoB-48 containing lipoproteins (Microsomal triglyceride transfer protein (MTP), apoB-48).
大体时间:At week 4 and week 12 (at the end of the two 4-weeks diets).
At week 4 and week 12 (at the end of the two 4-weeks diets).

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:Patrick Couture, MD,FRCP,PhD、Laval University

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

2014年1月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2016年5月1日

研究注册日期

首次提交

2013年8月30日

首先提交符合 QC 标准的

2013年9月3日

首次发布 (估计)

2013年9月4日

研究记录更新

最后更新发布 (估计)

2016年9月8日

上次提交的符合 QC 标准的更新

2016年9月7日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • INAF-PUFA

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