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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02649907
Recruitment Status : Active, not recruiting
First Posted : January 8, 2016
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Knut Mai, 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.


Condition or disease Intervention/treatment Phase
Weight Loss Hormone Disturbance Weight Gain Dietary Supplement: nutritional stimulation via different testmeals Other: Nutritional counseling Dietary Supplement: formula diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649907


Locations
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Germany
Charite Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Knut Mai, Prof Charite

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Knut Mai, Prof. Dr. med. Knut Mai (Principal Investigator and Clinical Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02649907    
Other Study ID Numbers: EA1/143/15
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Weight Gain
Endocrine System Diseases
Signs and Symptoms
Body Weight Changes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs