Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Incretine response to different nutritive stimulations
研究概览
简要总结
Investigative trial with aim of
- the description of the hormonal and metabolic response to meals containing different compositions of macronutrients
- the metabolic response to these test meals in dependance of the hepatic and muscular insulin sensitivity and abdominal adipose tissue and
- effects of a weight loss on the hormonal response to these test meals containing different compositions of macronutrients
Primary endpoint:
Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin response to a nutritive stimulation characterized by different nutritional composition
Secondary endpoints:
- differences of substrate utilization depending on the nutritive composition
- effects of different hepatic and muscular insulin sensitivity as well as impact of visceral fat mass on the hormonal and metabolic response
- effect of weight loss on the hormonal and metabolic response to different test meals
Study procedure:
After primary characterization 50 probands (male and female) will receive 3 different test meals within a randomised (meal order) controlled trial.
The three different test meals differ in nutritional composition. During consumption of the test meal a characterization of the endogenous hormonal response and appetite behaviour is performed.
A nutritional counselling is performed according to the guidelines of the German Nutrition Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal administration.
After analysis of the hormonal response to these 3 different testmeals follows a weight reduction period over 3 months. Afterwards reevaluation of the probands (again administration of 3 different test meals over a period of 3 weeks) will be performed.
Principal aim of the study:
Gain of information leading to the understanding of the hormonal regulation of food intake. The individual variability shall be determined with the aim of an identification of patient groups which show various intensities of the responses to different macronutrients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI>27 kg/m2
- •given written informed consent
排除标准
- •type 2 diabetes patients treated by insulin or drugs influencing incretin levels
- •lack of health insurance
- •weight changes > 5 kg in the past 2 months
- •pregnancy, breastfeeding
- •patients with:
- •severe heart failure
- •impaired hepatic or renal function
- •disturbed coagulation (biopsies will not be taken in those subjects)
- •infection, malabsorption
- •severe hypertension
- •cancer within the last 5 years
- •eating disorders or any other psychiatric condition that would interact with the trial intervention
- •any other endocrine disorder
- •changes of smoking habits or diets within the last 3 months prior to study inclusion *other severe chronic diseases
结局指标
主要结局
Incretine response to different nutritive stimulations
时间窗: 3 month
Concentration of GLP-1 after different test meals will be analysed by ELISA before and after weight loss
次要结局
- correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components(3 month)
- -Change of meal induced Ghrelin concentration during weight loss(3 month)
- Change of skeletal muscle mass after weight loss(3 month)
- To analyse the long term course of body weight after 12 month(12 months)
- -Change of hepatic insulin sensitivity after weight loss(3 month)
- To analyse the long term course of body weight after 24 month(24 months)
- Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components(3 month)
- -Change of meal induced GIP concentration during weight loss(3 month)
- To analyse the long term course of body weight after 36 month(36 months)
- To analyse the long term course of body weight after 48 month(48 months)
- -differences of lipolysis depending on the nutritional composition(3 month)
- Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components(3 month)
- Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components(3 month)
- -Change of meal induced GLP-1 concentration during weight loss(3 month)
- -Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects(3 month)
- -Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects(3 month)
- -Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects(3 month)
- -differences of substrate utilization depending on the nutritional composition(3 month)
- Change of fat distribution after weight loss(3 month)
- Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).(24 months)
研究者
Knut Mai
Prof. Dr. med. Knut Mai (Principal Investigator and Clinical Professor
Charite University, Berlin, Germany