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临床试验/NCT02225457
NCT02225457Unknown不适用

Study of the Determinants and Mechanisms of Adaptation of Metabolic Responses to Controlled Overfeeding in Female and Male Healthy Volunteers

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Change from baseline in insulin sensitivity

研究概览

简要总结

Obesity results from complex interactions between genetic and environmental factors, and are strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is defined as an excessive fat accumulation that presents a risk to health, a risk that is highly dependent upon the type of adipose tissue accumulation, whether visceral or sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory cells accumulation. Because of the well known sexual difference in fat accretion, this obesity-associated risk may also be very different for men and for women. In addition, recent data indicate that various factors such as the intestinal microbiota, but also the dietary intake of protective nutrients might be important determinants of the metabolic complications of obesity.

Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue accumulation during a period of controlled caloric over-nutrition, both in men and in women; 2) evaluate the potential protective effects of a supplementation with polyphenols on insulin resistance and other metabolic adaptations.

详细描述

To achieve these goals, healthy male and female volunteers will be enrolled into a one month longitudinal, prospective study on the influence of hypercaloric overfeeding (+50% of daily caloric needs) on different tissues (adipose tissue, muscle and blood).

They will be separated into two different groups: hypercaloric nutrition and placebo, and hypercaloric nutrition and polyphenols (2g/day), where polyphenols administration will be randomized and administered in a double blind fashion. Whole body and hepatic insulin sensitivity, total energy expenditure, glucose hepatic production, protein and gene expression in muscle, adipose tissue and blood as well as intestinal microbiota will be assessed at base line, and after one month of overfeeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • normal healthy male and female volunteer

排除标准

  • Diabetes mellitus
  • High blood pressure
  • Liver disease
  • Kidney disease

结局指标

主要结局

Change from baseline in insulin sensitivity

时间窗: baseline, day 31 of overfeeding

Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.

次要结局

  • Change from baseline in muscle and adipose tissue gene expression(Baseline, day 28 of overfeeding)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francois Pralong

Full Professor and Head, Cervice of Endocrinology, Diabetology and Metabolism

Centre Hospitalier Universitaire Vaudois

研究点 (2)

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