Weight LossRepDietNCT02649907
Effects of Weight Loss on Nutritional Mediated Hormone Secretion
A study testing nutritional stimulation via different testmeals, Nutritional counseling and formula diet in people with Weight Loss and Hormone Disturbance, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Hormone Disturbance, Weight Gain
- What is being tested?
- nutritional stimulation via different testmeals, Nutritional counseling and formula diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 12 Sep 2015to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI>27 kg/m2
- given written informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- the description of the hormonal and metabolic response to meals containing different compositions of macronutrients
- the metabolic response to these test meals in dependance of the hepatic and muscular insulin sensitivity and abdominal adipose tissue and
- effects of a weight loss on the hormonal response to these test meals containing different compositions of macronutrients
Read more
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.
- Conditions
- Weight Loss, Hormone Disturbance, Weight Gain
- Being tested
- nutritional stimulation via different testmeals, Nutritional counseling, formula diet
- Medical subject headings
- Weight Loss, Endocrine System Diseases, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional stimulation via different testmealsDietary supplement
nutritional stimulation of hormonal response through different testmeals
Nutritional counselingOther
nutritional counseling for healthy eating behaviour
formula dietDietary supplement
formula diet to help weight loss
| Study group | Role | What they receive |
|---|---|---|
| Weight loss | Experimental | 3 months weight loss intervention by behavioral intervention Receives: Dietary Supplement: nutritional stimulation via different testmeals; Other: Nutritional counseling; Dietary Supplement: formula diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretine response to different nutritive stimulations
Concentration of GLP-1 after different test meals will be analysed by ELISA before and after weight loss
Measured: 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
Measured: 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
Measured: 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
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))
Measured: 3 month
correlation of the GIP responses with the reduction of hunger (questionnaire)after a nutritive stimulation by different nutritional components
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))
Measured: 3 month
Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
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))
Measured: 3 month
Correlation of the insulin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
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))
Measured: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial thermogenesis will be assessed by indirect caloriemetry
Measured: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial glucose concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
Measured: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial pyruvate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
Measured: 3 month
-differences of substrate utilization depending on the nutritional composition
postprandial lactate concentration (physiological parameter) will be assessed in skeletal muscle and adipose tissue by microdialysis
Measured: 3 month
-differences of lipolysis depending on the nutritional composition
postprandial glycerol concentration (physiological parameter) will be assessed by microdialysis
Measured: 3 month
-Change of hepatic insulin sensitivity after weight loss
hepatic insulin sensitivity assessed via endogenous glucose production measured in mg/kg/min
Measured: 3 month
-Change of meal induced GLP-1 concentration during weight loss
Concentration of GLP-1 after different test meals will be analysed by ELISA
Measured: 3 month
-Change of meal induced GIP concentration during weight loss
Concentration of GIP after different test meals will be analysed by ELISA
Measured: 3 month
-Change of meal induced Ghrelin concentration during weight loss
Concentration of Ghrelin after different test meals will be analysed by ELISA
Measured: 3 month
-Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects
Insulin sensitivity assessed via insulin sensitivity index
Measured: 3 month
-Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects
Insulin sensitivity assessed via insulin sensitivity index
Measured: 3 month
-Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects
Insulin sensitivity assessed via insulin sensitivity index
Measured: 3 month
Change of fat distribution after weight loss
total fat mass will be assessed
Measured: 3 month
Change of fat distribution after weight loss
visceral fat mass will be assessed
Measured: 3 month
Change of fat distribution after weight loss
hepatic fat mass will be assessed
Measured: 3 month
Change of skeletal muscle mass after weight loss
skeletal muscle mass will be assessed
Measured: 3 month
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
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
Measured: 12 months
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
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
Measured: 12 months
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
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
Measured: 24 months
Prediction of weight regain (weight in kilograms and height in meters will be combined to report BMI in kg/m^2).
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
Measured: 24 months
To analyse the long term course of body weight after 12 month
Measurement of body weight after 12 months
Measured: 12 months
To analyse the long term course of body weight after 24 month
Measurement of body weight after 24 months
Measured: 24 months
To analyse the long term course of body weight after 36 month
Measurement of body weight after 36 months
Measured: 36 months
To analyse the long term course of body weight after 48 month
Measurement of body weight after 48 months
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start12 Sep 2015
- Primary completion19 Jun 2017
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Knut Mai, Charite University, Berlin, Germany
- Investigators
- Knut Mai, Prof, Principal investigator, Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649907
- Sponsor's protocol ID
- EA1/143/15
- Acronym
- RepDiet
- Status last verified
- Feb 2023
- First submitted
- 4 Nov 2015
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35303516Fleischmann 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.
PubMed 29191176
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients
- ClinicalTrials.gov ID
- NCT02649907
- Acronym / sponsor ID
- RepDiet / EA1/143/15
- Conditions
- Weight Loss, Hormone Disturbance, Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 12 Sep 2015 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigative trial with aim of
- the description of the hormonal and metabolic response to meals containing different compositions of macronutrients
- the metabolic response to these test meals in dependance of the hepatic and muscular insulin sensitivity and abdominal adipose tissue and
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss | Experimental | Dietary Supplement: nutritional stimulation via different testmeals, Other: Nutritional counseling, Dietary Supplement: formula diet3 months weight loss intervention by behavioral intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI>27 kg/m2
- given written informed consent
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional stimulation via different testmealsnutritional stimulation of hormonal response through different testmeals | Dietary supplement | Weight loss |
| Nutritional counselingnutritional counseling for healthy eating behaviour | Other | Weight loss |
| formula dietformula diet to help weight loss | Dietary supplement | Weight loss |
Primary outcome
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
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
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
28 secondary outcomes
Correlation of the GLP-1 responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
Time frame: 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
Correlation of the Ghrelin responses with the reduction of hunger (questionnaire) after a nutritive stimulation by different nutritional components
Time frame: 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
-differences of substrate utilization depending on the nutritional composition
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
Time frame: 3 month
-differences of substrate utilization depending on the nutritional composition
Time frame: 3 month
-differences of lipolysis depending on the nutritional composition
Time frame: 3 month
-Change of hepatic insulin sensitivity after weight loss
Time frame: 3 month
-Change of meal induced GLP-1 concentration during weight loss
Time frame: 3 month
-Change of meal induced GIP concentration during weight loss
Time frame: 3 month
-Change of meal induced Ghrelin concentration during weight loss
Time frame: 3 month
-Weight loss mediated changes of meal induced GLP-1 concentration in insulin resistant vs insulin sensitive subjects
Time frame: 3 month
-Weight loss mediated changes of meal induced GIP concentration in insulin resistant vs insulin sensitive subjects
Time frame: 3 month
-Weight loss mediated changes of meal induced Ghrelin concentration in insulin resistant vs insulin sensitive subjects
Time frame: 3 month
Change of fat distribution after weight loss
Time frame: 3 month
Change of fat distribution after weight loss
Time frame: 3 month
Change of fat distribution after weight loss
Time frame: 3 month
Change of skeletal muscle mass after weight loss
Time frame: 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
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
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
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
To analyse the long term course of body weight after 12 month
Time frame: 12 months
To analyse the long term course of body weight after 24 month
Time frame: 24 months
To analyse the long term course of body weight after 36 month
Time frame: 36 months
To analyse the long term course of body weight after 48 month
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 35303516Li 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.
- Derived from this study: PubMed 29191176Fleischmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Mai, Prof principal investigator
Charite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional stimulation via different testmeals, Nutritional counseling and formula diet in people with Weight Loss and Hormone Disturbance, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incretine response to different nutritive stimulations (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02649907, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.