Weight LossNCT01105143
Effects of Negative Energy Balance on Muscle Mass Regulation
A study testing multimodal lifestyle intervention in people with Weight Loss and Obesity, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators here propose to perform a prospective randomized intervention trial in post-menopausal women to investigate the endocrine network, which contributes to the changes in skeletal muscle mass during weight loss. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Skeletal Muscle
- What is being tested?
- multimodal lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to May 2017
- 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 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 27 kg/m2 (adults)
- postmenopausal state
Who cannot join
- weight loss of more than 5kg in the last 2 months x
- unhealthy patients with: severe chronic diseases including cancer within the last 5 years, severe heart disease, severe impairment of hepatic or renal function, severe anaemia or disturbed coagulation
- eating disorders or any other psychiatric condition that would interact with the trial intervention
- malabsorption
- acute or chronic infections
- severe hypertension
Show all 10Show fewer
- myopathy
- food allergies
- any other uncontrolled endocrine disorder
- changes of smoking habits, diets or medication that strongly affects energy homeostasis within the last 3 months prior to study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
The investigators here propose to perform a prospective randomized intervention trial in post-menopausal women to investigate the endocrine network, which contributes to the changes in skeletal muscle mass during weight loss.
- Conditions
- Weight Loss, Obesity, Skeletal Muscle, Insulin Sensitivity/Resistance
- Being tested
- multimodal lifestyle intervention, placebo
- Keywords
- weight loss, muscle mass
- Medical subject headings
- Weight Loss, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal lifestyle interventionBehavioural
multimodal lifestyle intervention will be performed to reduce body weight
placeboBehavioural
no intervention, only follow up
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Active comparator | Multimodal lifestyle intervention to reduce body weight Receives: Behavioral: multimodal lifestyle intervention |
| placebo | Placebo comparator | placebo Receives: Behavioral: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)
Measured: 4 months
Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
Analysis of muscle mass (in % of body weight)
Measured: 4 months
Secondary outcomes (6)
Effects on energy expenditure
Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient
Measured: 4 months
Effects on myocellular and adipose tissue metabolism and substrate utilization
Measurement of myocellular and adipose metabolism using microdialysis (glycerol (µmol/l), lactate (mmol/l), pyruvate (µmol/l), glucose (mmol/l)) during oral glucose load (180 minutes)
Measured: 4 months
Effects on myocellular and adipose tissue mRNA expression
Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts
Measured: 4 months
Weight regain
Analysis of body weight regain (BMI; kg/m2) during follow up
Measured: 24 months
Fat mass
Analysis of body fat (kg and %)
Measured: 24 months
Measurement of human gut microbiome at baseline, during weight loos, after weight loss (negative energy balance) and during stabilized modification of body composition 4 weeks after weight loss
16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMar 2012
- Primary completionMay 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Professor Joachim Spranger, Charite University, Berlin, Germany
- Investigators
- Knut Mai, Prof, Principal investigator, Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105143
- Sponsor's protocol ID
- EA 20100415
- Status last verified
- Dec 2017
- First submitted
- 14 Apr 2010
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Spranger L, Weiner J, Bredow J, Zeitz U, Grittner U, Boschmann M, Dickmann S, Stobaus N, Schwartzenberg RJ, Brachs M, Spranger J, Mai K. Thrifty energy phenotype predicts weight regain in postmenopausal women with overweight or obesity and is related to FGFR1 signaling. Clin Nutr. 2023 Apr;42(4):559-567. doi: 10.1016/j.clnu.2023.02.020. Epub 2023 Feb 24.
PubMed 36863292Sbierski-Kind J, Grenkowitz S, Schlickeiser S, Sandforth A, Friedrich M, Kunkel D, Glauben R, Brachs S, Mai K, Thurmer A, Radonic A, Drechsel O, Turnbaugh PJ, Bisanz JE, Volk HD, Spranger J, von Schwartzenberg RJ. Effects of caloric restriction on the gut microbiome are linked with immune senescence. Microbiome. 2022 Apr 4;10(1):57. doi: 10.1186/s40168-022-01249-4.
PubMed 35379337Koppel N, Bisanz JE, Pandelia ME, Turnbaugh PJ, Balskus EP. Discovery and characterization of a prevalent human gut bacterial enzyme sufficient for the inactivation of a family of plant toxins. Elife. 2018 May 15;7:e33953. doi: 10.7554/eLife.33953.
PubMed 29761785
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Negative Energy Balance on Muscle Mass Regulation
- ClinicalTrials.gov ID
- NCT01105143
- Acronym / sponsor ID
- EA 20100415
- Conditions
- Weight Loss, Obesity, Skeletal Muscle, Insulin Sensitivity/Resistance
- Keywords
- weight loss, muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Mar 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Apr 2010 (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.
The investigators here propose to perform a prospective randomized intervention trial in post-menopausal women to investigate the endocrine network, which contributes to the changes in skeletal muscle mass during weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Active comparator | Behavioral: multimodal lifestyle interventionMultimodal lifestyle intervention to reduce body weight |
| placebo | Placebo comparator | Behavioral: placeboplacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 27 kg/m2 (adults)
- postmenopausal state
Key exclusion criteria (10 listed)
- weight loss of more than 5kg in the last 2 months x
- unhealthy patients with: severe chronic diseases including cancer within the last 5 years, severe heart disease, severe impairment of hepatic or renal function, severe anaemia or disturbed coagulation
- eating disorders or any other psychiatric condition that would interact with the trial intervention
- malabsorption
- acute or chronic infections
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 |
|---|---|---|
| multimodal lifestyle interventionmultimodal lifestyle intervention will be performed to reduce body weight | Behavioural | lifestyle intervention |
| placebono intervention, only follow up | Behavioural | placebo |
Primary outcome
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
Time frame: 4 months
Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)
Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
Time frame: 4 months
Analysis of muscle mass (in % of body weight)
6 secondary outcomes
Effects on energy expenditure
Time frame: 4 months
Effects on myocellular and adipose tissue metabolism and substrate utilization
Time frame: 4 months
Effects on myocellular and adipose tissue mRNA expression
Time frame: 4 months
Weight regain
Time frame: 24 months
Fat mass
Time frame: 24 months
Measurement of human gut microbiome at baseline, during weight loos, after weight loss (negative energy balance) and during stabilized modification of body composition 4 weeks after weight loss
Time frame: 4 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 20 Dec 2017.
- Derived from this study: PubMed 36863292Spranger L, Weiner J, Bredow J, Zeitz U, Grittner U, Boschmann M, Dickmann S, Stobaus N, Schwartzenberg RJ, Brachs M, Spranger J, Mai K. Thrifty energy phenotype predicts weight regain in postmenopausal women with overweight or obesity and is related to FGFR1 signaling. Clin Nutr. 2023 Apr;42(4):559-567. doi: 10.1016/j.clnu.2023.02.020. Epub 2023 Feb 24.
- Derived from this study: PubMed 35379337Sbierski-Kind J, Grenkowitz S, Schlickeiser S, Sandforth A, Friedrich M, Kunkel D, Glauben R, Brachs S, Mai K, Thurmer A, Radonic A, Drechsel O, Turnbaugh PJ, Bisanz JE, Volk HD, Spranger J, von Schwartzenberg RJ. Effects of caloric restriction on the gut microbiome are linked with immune senescence. Microbiome. 2022 Apr 4;10(1):57. doi: 10.1186/s40168-022-01249-4.
- Derived from this study: PubMed 29761785Koppel N, Bisanz JE, Pandelia ME, Turnbaugh PJ, Balskus EP. Discovery and characterization of a prevalent human gut bacterial enzyme sufficient for the inactivation of a family of plant toxins. Elife. 2018 May 15;7:e33953. doi: 10.7554/eLife.33953.
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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 multimodal lifestyle intervention in people with Weight Loss and Obesity, 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 10 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 20 Dec 2017. 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. Some participants in this study may receive a placebo. 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?
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss. (time frame: 4 months). The study lists 2 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 NCT01105143, which also lists 3 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 20 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.