NCT02649907

Brief Summary

Investigative trial with aim of

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

November 4, 2015

Last Update Submit

February 7, 2023

Conditions

Weight LossHormone DisturbanceWeight Gain

Outcome Measures

Primary Outcomes (3)

  • Incretine response to different nutritive stimulations

    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

    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

    Concentration of Ghrelin after different test meals will be analysed by ELISA before and after weight loss

    3 month

Secondary Outcomes (28)

  • Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components

    3 month

  • correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components

    3 month

  • Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components

    3 month

  • Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components

    3 month

  • -differences of substrate utilization depending on the nutritional composition

    3 month

  • +23 more secondary outcomes

Study Arms (1)

Weight loss

EXPERIMENTAL

3 months weight loss intervention by behavioral intervention

Dietary Supplement: nutritional stimulation via different testmealsOther: Nutritional counselingDietary Supplement: formula diet

Interventions

nutritional stimulation via different testmealsDIETARY_SUPPLEMENT

nutritional stimulation of hormonal response through different testmeals

Weight loss
Nutritional counselingOTHER

nutritional counseling for healthy eating behaviour

Weight loss
formula dietDIETARY_SUPPLEMENT

formula diet to help weight loss

Weight loss

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>27 kg/m2
  • given written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Campus Mitte

Berlin, 10117, Germany

Location

Related Publications (2)

  • 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.

    PMID: 35303516DERIVED

  • 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.

    PMID: 29191176DERIVED

MeSH Terms

Conditions

Weight LossEndocrine System DiseasesWeight Gain

Interventions

Nutrition AssessmentFood, Formulated

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthFoods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Knut Mai, Prof

    Charite

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Knut Mai (Principal Investigator and Clinical Professor

Study Record Dates

First Submitted

November 4, 2015

First Posted

January 8, 2016

Study Start

September 12, 2015

Primary Completion

June 19, 2017

Study Completion

May 31, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

DE(1)