Polyphenols: Protection From Overfeeding-induced Insulin Resistance?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Peripheral insulin sensitivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Peripheral insulin sensitivity
时间窗: 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.
次要结局
- Modification in intestinal microbiota(Before and after the 31 days of overfeeding)
- Anthropometry, Fat quantification and Abdominal fat distribution(During 31 days)
- Fasting and Postprandial partitioning of exogenous lipid(Fasting and during all the postprandial period (0-300 minutes))
- Hepatic insulin sensitivity(before and after the 31 days of overfeeding)
- Change in genes expression in adipose and muscle tissues(Before and after the 31 days of overfeeding)
- Energy expenditure and substrate oxidation with indirect calorimetry(Fasting and during all the postprandial period (0-300 minutes))