Effects of Weight Loss on Nutritional Mediated Hormone Secretion

Weight Loss Clinical Trial

— RepDiet  

Official title:

Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649907
• Other study ID #: EA1/143/15
• Status: Completed
• Phase: N/A
• Start date: September 12, 2015
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 31, 2021
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI>27 kg/m2

• given written informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Body Weight
• Endocrine System Diseases
• Hormone Disturbance
• Weight Gain
• Weight Loss

Intervention

Dietary Supplement:
• nutritional stimulation via different testmeals
nutritional stimulation of hormonal response through different testmeals

Other:
• Nutritional counseling
nutritional counseling for healthy eating behaviour

Dietary Supplement:
• formula diet
formula diet to help weight loss

Locations

Country	Name	City	State
Germany	Charite Campus Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incretine response to different nutritive stimulations	Concentration of GLP-1 after different test meals will be analysed by ELISA before and after weight loss	3 month
Primary	Incretine response to different nutritive stimulations	Concentration of GIP after different test meals will be analysed by ELISA before and after weight loss	3 month
Primary	Incretine response to different nutritive stimulations	Concentration of Ghrelin after different test meals will be analysed by ELISA before and after weight loss	3 month
Secondary	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))	3 month
Secondary	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))	3 month
Secondary	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))	3 month
Secondary	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))	3 month
Secondary	-differences of substrate utilization depending on the nutritional composition	postprandial thermogenesis will be assessed by indirect caloriemetry	3 month
Secondary	-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	3 month
Secondary	-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	3 month
Secondary	-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	3 month
Secondary	-differences of lipolysis depending on the nutritional composition	postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis	3 month
Secondary	-Change of hepatic insulin sensitivity after weight loss	hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min	3 month
Secondary	-Change of meal induced GLP-1 concentration during weight loss	Concentration of GLP-1 after different test meals will be analysed by ELISA	3 month
Secondary	-Change of meal induced GIP concentration during weight loss	Concentration of GIP after different test meals will be analysed by ELISA	3 month
Secondary	-Change of meal induced Ghrelin concentration during weight loss	Concentration of Ghrelin after different test meals will be analysed by ELISA	3 month
Secondary	-Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects	Insulin sensitivity assessed via insulin sensitivity index	3 month
Secondary	-Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects	Insulin sensitivity assessed via insulin sensitivity index	3 month
Secondary	-Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects	Insulin sensitivity assessed via insulin sensitivity index	3 month
Secondary	Change of fat distribution after weight loss	total fat mass will be assessed	3 month
Secondary	Change of fat distribution after weight loss	visceral fat mass will be assessed	3 month
Secondary	Change of fat distribution after weight loss	hepatic fat mass will be assessed	3 month
Secondary	Change of skeletal muscle mass after weight loss	skeletal muscle mass will be assessed	3 month
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	To analyse the long term course of body weight after 12 month	Measurement of body weight after 12 months	12 months
Secondary	To analyse the long term course of body weight after 24 month	Measurement of body weight after 24 months	24 months
Secondary	To analyse the long term course of body weight after 36 month	Measurement of body weight after 36 months	36 months
Secondary	To analyse the long term course of body weight after 48 month	Measurement of body weight after 48 months	48 months