Effects of Weight Loss on Nutritional Mediated Hormone Secretion (RepDiet)

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

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 Overview

• Status: Completed
• Conditions: Weight Loss; Weight Gain; Hormone Disturbance
• Intervention / Treatment: Dietary supplement: nutritional stimulation via different testmeals; Other: Nutritional counseling; Dietary supplement: formula diet

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Campus Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Weight loss; 3 months weight loss intervention by behavioral 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
-differences of substrate utilization depending on the nutritional composition	postprandial thermogenesis will be assessed by indirect caloriemetry	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	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	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	3 month
-differences of lipolysis depending on the nutritional composition	postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis	3 month
-Change of hepatic insulin sensitivity after weight loss	hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min	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	3 month
-Change of meal induced GIP concentration during weight loss	Concentration of GIP after different test meals will be analysed by ELISA	3 month
-Change of meal induced Ghrelin concentration during weight loss	Concentration of Ghrelin after different test meals will be analysed by ELISA	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	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	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	3 month
Change of fat distribution after weight loss	total fat mass will be assessed	3 month
Change of fat distribution after weight loss	visceral fat mass will be assessed	3 month
Change of fat distribution after weight loss	hepatic fat mass will be assessed	3 month
Change of skeletal muscle mass after weight loss	skeletal muscle mass will be assessed	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	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	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	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	24 months
To analyse the long term course of body weight after 12 month	Measurement of body weight after 12 months	12 months
To analyse the long term course of body weight after 24 month	Measurement of body weight after 24 months	24 months
To analyse the long term course of body weight after 36 month	Measurement of body weight after 36 months	36 months
To analyse the long term course of body weight after 48 month	Measurement of body weight after 48 months	48 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Li L, Decker AM, Stobaus N, Beer F, Grittner U, Spranger J, Mai K. Weight loss did not modify macronutrient specific response of hormones and satiety in overweight and obese people without metabolic disease - results from a clinical trial. Clin Nutr. 2022 Apr;41(4):948-957. doi: 10.1016/j.clnu.2022.02.004. Epub 2022 Feb 19.
• Fleischmann R, Decker AM, Kraft A, Mai K, Schmidt S. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial. BMC Med Res Methodol. 2017 Dec 1;17(1):153. doi: 10.1186/s12874-017-0429-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2015
• Primary Completion (ACTUAL): June 19, 2017
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (ESTIMATE): January 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight; Weight Gain; Endocrine System Diseases
• Other Study ID Numbers: EA1/143/15