Clinical trial NCT02649907: Effects of Weight Loss on Nutritional Mediated Hormone Secretion
Official title: Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Hormone Disturbance
Weight Gain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incretine response to different nutritive stimulations
timeFrame: 3 month
measure: Incretine response to different nutritive stimulations
timeFrame: 3 month
measure: Incretine response to different nutritive stimulations
timeFrame: 3 month
Secondary outcomes:
measure: Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
timeFrame: 3 month
measure: correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components
timeFrame: 3 month
measure: Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
timeFrame: 3 month
measure: Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
timeFrame: 3 month
measure: -differences of substrate utilization depending on the nutritional composition
timeFrame: 3 month
measure: -differences of substrate utilization depending on the nutritional composition
timeFrame: 3 month
measure: -differences of substrate utilization depending on the nutritional composition
timeFrame: 3 month
measure: -differences of substrate utilization depending on the nutritional composition
timeFrame: 3 month
measure: -differences of lipolysis depending on the nutritional composition
timeFrame: 3 month
measure: -Change of hepatic insulin sensitivity after weight loss
timeFrame: 3 month
measure: -Change of meal induced GLP-1 concentration during weight loss
timeFrame: 3 month
measure: -Change of meal induced GIP concentration during weight loss
timeFrame: 3 month
measure: -Change of meal induced Ghrelin concentration during weight loss
timeFrame: 3 month
measure: -Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects
timeFrame: 3 month
measure: -Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects
timeFrame: 3 month
measure: -Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects
timeFrame: 3 month
measure: Change of fat distribution after weight loss
timeFrame: 3 month
measure: Change of fat distribution after weight loss
timeFrame: 3 month
measure: Change of fat distribution after weight loss
timeFrame: 3 month
measure: Change of skeletal muscle mass after weight loss
timeFrame: 3 month
measure: Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
timeFrame: 12 months
measure: Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
timeFrame: 12 months
measure: Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
timeFrame: 24 months
measure: Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
timeFrame: 24 months
measure: To analyse the long term course of body weight after 12 month
timeFrame: 12 months
measure: To analyse the long term course of body weight after 24 month
timeFrame: 24 months
measure: To analyse the long term course of body weight after 36 month
timeFrame: 36 months
measure: To analyse the long term course of body weight after 48 month
timeFrame: 48 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Campus Mitte
Study officials:
affiliation: Charite
name: Knut Mai, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.