Study of the Determinants and Mechanisms of Adaptation of Metabolic Responses to Controlled Overfeeding in Female and Male Healthy Volunteers
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
- 是
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
Francois Pralong
Full Professor and Head, Cervice of Endocrinology, Diabetology and Metabolism
Centre Hospitalier Universitaire Vaudois
