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

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ClinicalTrials.gov Identifier: NCT02649907
Recruitment Status : Unknown
Verified January 2016 by Knut Mai, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
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
Hormonal Response to Different Compositions of Macronutrients Dietary Supplement: nutritional stimulation via different testmeals Other: Nutritional counseling Dietary Supplement: formula diet Not Applicable

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
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 ]
    incretin response to different test meals will be analysed before and after weight loss


Secondary Outcome Measures :
  1. -association of the hormonal responses with the reduction of hunger sensation after a nutritive stimulation by different nutritional components [ Time Frame: 3 month ]
  2. -differences of substrate utilization depending on the nutritional composition [ Time Frame: 3 month ]
    assessed in mg/min

  3. -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

  4. -Change of meal induced GLP-1, GIP and ghrelin response during weight loss [ Time Frame: 3 month ]
  5. -Weight loss mediated changes of meal induced GLP-1 and GIP, ghrelin response in insulin resistant vs insulin sensitive subjects [ Time Frame: 3 month ]
    Insulin sensitivity assessed via Insulin sensitivity index

  6. Change of visceral fat mass after weight loss [ Time Frame: 3 month ]
    visceral fat mass assessed in ml



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  • 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
Germany
Charite Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Knut Mai, MD       knut.mai@charite.de   
Contact: Joachim Spranger, Prof       joachim.spranger@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Knut Mai, Dr. med. Knut Mai, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02649907     History of Changes
Other Study ID Numbers: EA1/143/15
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs