NCT02649907: RepDiet

Effects of Weight Loss on Nutritional Mediated Hormone Secretion

Completed NA Last updated 8 February 2023

What this trial tests

NA trial testing nutritional stimulation via different testmeals in Weight Loss in 32 participants. Completed in 31 May 2021.

Timeline

12 September 2015

Primary endpoint
19 June 2017

31 May 2021

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	12 September 2015
Primary completion	19 June 2017
Estimated completion	31 May 2021
Sites	1 location across Germany

Drugs / interventions tested

• nutritional stimulation via different testmeals
• Nutritional counseling
• formula diet

Conditions studied

• Weight Loss — all drugs for Weight Loss →
• Hormone Disturbance — all drugs for Hormone Disturbance →
• Weight Gain — all drugs for Weight Gain →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 18 to 80, any sex, with Weight Loss or Hormone Disturbance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.
   Fleischmann R, Decker AM, Kraft A, Mai K, et al · · 2017 · cited 20× · PMID 29191176 · DOI 10.1186/s12874-017-0429-y
2. 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.
   Li L, Decker AM, Stobäus N, Beer F, et al · · 2022 · cited 1× · PMID 35303516 · DOI 10.1016/j.clnu.2022.02.004