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

Charité University Medicine Berlin

Status: Completed

Conditions: Weight Loss; Weight Gain; Hormone Disturbance

Treatments: Other: Nutritional counseling; Dietary Supplement: nutritional stimulation via different testmeals; Dietary Supplement: formula diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02649907

EA1/143/15

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Weight loss

Experimental group

Description:

3 months weight loss intervention by behavioral intervention

Treatment:

Dietary Supplement: nutritional stimulation via different testmeals

Dietary Supplement: formula diet

Other: Nutritional counseling