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Completed

NCT Number: NCT02649907

Effects of Weight Loss on Nutritional Mediated Hormone Secretion

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Endocrine System Diseases Hormone Disturbance Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite Campus Mitte

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutritional stimulation via different testmeals

Dietary Supplement

nutritional stimulation of hormonal response through different testmeals

nutritional counseling

Other

nutritional counseling for healthy eating behaviour

formula diet

Dietary Supplement

formula diet to help weight loss

Primary outcomes

  1. Incretine response to different nutritive stimulations

    Time frame: 3 month

    Concentration of GLP-1 after different test meals will be analysed by ELISA before and after weight loss

  2. Incretine response to different nutritive stimulations

    Time frame: 3 month

    Concentration of GIP after different test meals will be analysed by ELISA before and after weight loss

  3. Incretine response to different nutritive stimulations

    Time frame: 3 month

    Concentration of Ghrelin after different test meals will be analysed by ELISA before and after weight loss

Secondary outcomes

  1. Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components

    Time frame: 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))

  2. correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components

    Time frame: 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))

  3. Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components

    Time frame: 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))

  4. Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components

    Time frame: 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))

  5. -differences of substrate utilization depending on the nutritional composition

    Time frame: 3 month

    postprandial thermogenesis will be assessed by indirect caloriemetry

  6. -differences of substrate utilization depending on the nutritional composition

    Time frame: 3 month

    postprandial glucose concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis

  7. -differences of substrate utilization depending on the nutritional composition

    Time frame: 3 month

    postprandial pyruvate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis

  8. -differences of substrate utilization depending on the nutritional composition

    Time frame: 3 month

    postprandial lactate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis

  9. -differences of lipolysis depending on the nutritional composition

    Time frame: 3 month

    postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis

  10. -Change of hepatic insulin sensitivity after weight loss

    Time frame: 3 month

    hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min

  11. -Change of meal induced GLP-1 concentration during weight loss

    Time frame: 3 month

    Concentration of GLP-1 after different test meals will be analysed by ELISA

  12. -Change of meal induced GIP concentration during weight loss

    Time frame: 3 month

    Concentration of GIP after different test meals will be analysed by ELISA

  13. -Change of meal induced Ghrelin concentration during weight loss

    Time frame: 3 month

    Concentration of Ghrelin after different test meals will be analysed by ELISA

  14. -Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects

    Time frame: 3 month

    Insulin sensitivity assessed via insulin sensitivity index

  15. -Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects

    Time frame: 3 month

    Insulin sensitivity assessed via insulin sensitivity index

  16. -Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects

    Time frame: 3 month

    Insulin sensitivity assessed via insulin sensitivity index

  17. Change of fat distribution after weight loss

    Time frame: 3 month

    total fat mass will be assessed

  18. Change of fat distribution after weight loss

    Time frame: 3 month

    visceral fat mass will be assessed

  19. Change of fat distribution after weight loss

    Time frame: 3 month

    hepatic fat mass will be assessed

  20. Change of skeletal muscle mass after weight loss

    Time frame: 3 month

    skeletal muscle mass will be assessed

  21. Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).

    Time frame: 12 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

  22. Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).

    Time frame: 12 months

    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

  23. Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).

    Time frame: 24 months

    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. Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).

    Time frame: 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

  25. To analyse the long term course of body weight after 12 month

    Time frame: 12 months

    Measurement of body weight after 12 months

  26. To analyse the long term course of body weight after 24 month

    Time frame: 24 months

    Measurement of body weight after 24 months

  27. To analyse the long term course of body weight after 36 month

    Time frame: 36 months

    Measurement of body weight after 36 months

  28. To analyse the long term course of body weight after 48 month

    Time frame: 48 months

    Measurement of body weight after 48 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: RepDiet

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Jan 8, 2016
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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