Effects of Weight Loss on Nutritional Mediated Hormone Secretion
- Conditions
- Weight LossHormone DisturbanceWeight Gain
- Interventions
- Dietary Supplement: nutritional stimulation via different testmealsOther: Nutritional counselingDietary Supplement: formula diet
- Registration Number
- NCT02649907
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- BMI>27 kg/m2
- given written informed consent
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Weight loss nutritional stimulation via different testmeals 3 months weight loss intervention by behavioral intervention Weight loss formula diet 3 months weight loss intervention by behavioral intervention Weight loss Nutritional counseling 3 months weight loss intervention by behavioral intervention
- Primary Outcome Measures
Name Time Method Incretine response to different nutritive stimulations 3 month Concentration of Ghrelin after different test meals will be analysed by ELISA before and after weight loss
- Secondary Outcome Measures
Name Time Method -Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects 3 month Insulin sensitivity assessed via insulin sensitivity index
Change of fat distribution after weight loss 3 month hepatic fat mass will be assessed
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2). 24 months 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
correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components 3 month 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))
-Change of meal induced Ghrelin concentration during weight loss 3 month Concentration of Ghrelin after different test meals will be analysed by ELISA
Change of skeletal muscle mass after weight loss 3 month skeletal muscle mass will be assessed
To analyse the long term course of body weight after 12 month 12 months Measurement of body weight after 12 months
-differences of substrate utilization depending on the nutritional composition 3 month postprandial lactate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
-Change of hepatic insulin sensitivity after weight loss 3 month hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min
To analyse the long term course of body weight after 24 month 24 months Measurement of body weight after 24 months
Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components 3 month 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))
-Change of meal induced GIP concentration during weight loss 3 month Concentration of GIP after different test meals will be analysed by ELISA
To analyse the long term course of body weight after 36 month 36 months Measurement of body weight after 36 months
To analyse the long term course of body weight after 48 month 48 months Measurement of body weight after 48 months
-differences of lipolysis depending on the nutritional composition 3 month postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis
Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components 3 month 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))
Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components 3 month 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))
-Change of meal induced GLP-1 concentration during weight loss 3 month Concentration of GLP-1 after different test meals will be analysed by ELISA
-Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects 3 month Insulin sensitivity assessed via insulin sensitivity index
-Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects 3 month Insulin sensitivity assessed via insulin sensitivity index
Trial Locations
- Locations (1)
Charite Campus Mitte
🇩🇪Berlin, Germany