Investigative trial with aim of 1. the description of the hormonal and metabolic response to meals containing different compositions of macronutrients 2. the metabolic response to these test meals in dependance of the hepatic and muscular insulin sensitivity and abdominal adipose tissue and 3. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
nutritional stimulation of hormonal response through different testmeals
nutritional counseling for healthy eating behaviour
formula diet to help weight loss
Charite Campus Mitte
Berlin, Germany
Incretine response to different nutritive stimulations
Concentration of GLP-1 after different test meals will be analysed by ELISA before and after weight loss
Time frame: 3 month
Incretine response to different nutritive stimulations
Concentration of GIP after different test meals will be analysed by ELISA before and after weight loss
Time frame: 3 month
Incretine response to different nutritive stimulations
Concentration of Ghrelin after different test meals will be analysed by ELISA before and after weight loss
Time frame: 3 month
Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
GLP-1 (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more))
Time frame: 3 month
correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components
GIP (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more))
Time frame: 3 month
Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
Ghrelin (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more))
Time frame: 3 month
Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
insulin (concentration) will be measured by ELISA, hunger feeling will be measured by questionnaire using a visual analog score (from 1 (less) to 10 (more))
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial thermogenesis will be assessed by indirect caloriemetry
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial glucose concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial pyruvate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial lactate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
Time frame: 3 month
-differences of lipolysis depending on the nutritional composition
postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis
Time frame: 3 month
-Change of hepatic insulin sensitivity after weight loss
hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min
Time frame: 3 month
-Change of meal induced GLP-1 concentration during weight loss
Concentration of GLP-1 after different test meals will be analysed by ELISA
Time frame: 3 month
-Change of meal induced GIP concentration during weight loss
Concentration of GIP after different test meals will be analysed by ELISA
Time frame: 3 month
-Change of meal induced Ghrelin concentration during weight loss
Concentration of Ghrelin after different test meals will be analysed by ELISA
Time frame: 3 month
-Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects
Insulin sensitivity assessed via insulin sensitivity index
Time frame: 3 month
-Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects
Insulin sensitivity assessed via insulin sensitivity index
Time frame: 3 month
-Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects
Insulin sensitivity assessed via insulin sensitivity index
Time frame: 3 month
Change of fat distribution after weight loss
total fat mass will be assessed
Time frame: 3 month
Change of fat distribution after weight loss
visceral fat mass will be assessed
Time frame: 3 month
Change of fat distribution after weight loss
hepatic fat mass will be assessed
Time frame: 3 month
Change of skeletal muscle mass after weight loss
skeletal muscle mass will be assessed
Time frame: 3 month
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of body weight regain. Linear and logistic regression models will be used to identify predictive biomarkers
Time frame: 12 months
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of insulin sensitivity. Linear and logistic regression models will be used to identify predictive biomarkers
Time frame: 12 months
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of insulin sensitivity. Linear and logistic regression models will be used to identify predictive biomarkers
Time frame: 24 months
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
Analysis of the predictive impact of hormones like GLP-1, Ghrelin, GIP and insulin in the context of body weight regain. Linear and logistic regression models will be used to identify predictive biomarkers
Time frame: 24 months
To analyse the long term course of body weight after 12 month
Measurement of body weight after 12 months
Time frame: 12 months
To analyse the long term course of body weight after 24 month
Measurement of body weight after 24 months
Time frame: 24 months
To analyse the long term course of body weight after 36 month
Measurement of body weight after 36 months
Time frame: 36 months
To analyse the long term course of body weight after 48 month
Measurement of body weight after 48 months
Time frame: 48 months
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