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Polyphenols and Overfeeding (Poly-Nut)

2017年8月22日 更新者:Hospices Civils de Lyon

Polyphenols: Protection From Overfeeding-induced Insulin Resistance?

Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. The model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human.

The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal.

During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.

研究概览

研究类型

介入性

注册 (实际的)

42

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

      • Pierre-bénite、法国、69495
        • Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)

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 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Male
  • Aged from 18 to 55 years
  • Body Mass Index of 23 to 27 kg/m²
  • Normal blood pressure
  • Fasting glycemia < 7 mmol/L
  • CRPus < 10mg/L
  • Triglycerides ≤ 3mmol/L

Exclusion Criteria:

  • Medical or surgical history which may affect the results (renal -cardiovascular - hepatic- endocrine-inflammatory diseases)
  • Subjects under treatment which may interfere with the measured parameters
  • Eating disorder
  • Intensive sportive activity
  • Dairy products allergy or intolerance

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:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:2g of grape polyphenol extract supplement
Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
安慰剂比较:2g of placebo (lactose)
Men will have to consume daily 2g of placebo during the 31 days of overfeeding.
Men will have to consume daily 2g of placebo during the 31 days of overfeeding.

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
Peripheral insulin sensitivity
大体时间:During 31 days
Volunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.
During 31 days

次要结果测量

结果测量
措施说明
大体时间
Hepatic insulin sensitivity
大体时间:before and after the 31 days of overfeeding
Endogenous glucose production (EGP) will be determined during the last 30 minutes of the low-dose insulin infusion.
before and after the 31 days of overfeeding
Change in genes expression in adipose and muscle tissues
大体时间:Before and after the 31 days of overfeeding
RT-PCR
Before and after the 31 days of overfeeding
Anthropometry, Fat quantification and Abdominal fat distribution
大体时间:During 31 days
Weight, height, waist and hip circumferences, fat mass using dual x-ray absorptiometry (DEXA) and abdominal fat distribution using resonance magnetic imaging (RMI).
During 31 days
Fasting and Postprandial partitioning of exogenous lipid
大体时间:Fasting and during all the postprandial period (0-300 minutes)
13C enrichment will be measured in blood samples and breath test during a test meal performed before and after the 31 days of overfeeding.
Fasting and during all the postprandial period (0-300 minutes)
Modification in intestinal microbiota
大体时间:Before and after the 31 days of overfeeding
Feces analyses
Before and after the 31 days of overfeeding
Energy expenditure and substrate oxidation with indirect calorimetry
大体时间:Fasting and during all the postprandial period (0-300 minutes)
Energy metabolism will be measured before and after the 31 days of overfeeding.
Fasting and during all the postprandial period (0-300 minutes)

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:Martine LAVILLE, MD, PhD、Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)

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 (实际的)

2014年2月1日

初级完成 (实际的)

2017年5月1日

研究完成 (实际的)

2017年5月1日

研究注册日期

首次提交

2014年5月13日

首先提交符合 QC 标准的

2014年5月20日

首次发布 (估计)

2014年5月23日

研究记录更新

最后更新发布 (实际的)

2017年8月23日

上次提交的符合 QC 标准的更新

2017年8月22日

最后验证

2017年8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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