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

February 7, 2023 updated by: Knut Mai, Charite University, Berlin, Germany

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 month
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 month
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
3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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))
3 month
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 month
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))
3 month
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))
3 month
-differences of substrate utilization depending on the nutritional composition
Time Frame: 3 month
postprandial thermogenesis will be assessed by indirect caloriemetry
3 month
-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
3 month
-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
3 month
-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
3 month
-differences of lipolysis depending on the nutritional composition
Time Frame: 3 month
postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis
3 month
-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
3 month
-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
3 month
-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
3 month
-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
3 month
-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
3 month
-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
3 month
-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
3 month
Change of fat distribution after weight loss
Time Frame: 3 month
total fat mass will be assessed
3 month
Change of fat distribution after weight loss
Time Frame: 3 month
visceral fat mass will be assessed
3 month
Change of fat distribution after weight loss
Time Frame: 3 month
hepatic fat mass will be assessed
3 month
Change of skeletal muscle mass after weight loss
Time Frame: 3 month
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).
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
12 months
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
12 months
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 months
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
24 months
To analyse the long term course of body weight after 12 month
Time Frame: 12 months
Measurement of body weight after 12 months
12 months
To analyse the long term course of body weight after 24 month
Time Frame: 24 months
Measurement of body weight after 24 months
24 months
To analyse the long term course of body weight after 36 month
Time Frame: 36 months
Measurement of body weight after 36 months
36 months
To analyse the long term course of body weight after 48 month
Time Frame: 48 months
Measurement of body weight after 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA1/143/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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