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Effects of Negative Energy Balance on Muscle Mass Regulation

Primary Purpose

Weight Loss, Obesity, Skeletal Muscle

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
multimodal lifestyle intervention
placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring weight loss, muscle mass

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI > 27 kg/m2 (adults)
  • postmenopausal state

Exclusion criteria:

  • 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
  • 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

Sites / Locations

  • Charite

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

lifestyle intervention

placebo

Arm Description

Multimodal lifestyle intervention to reduce body weight

placebo

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Effects on energy expenditure
Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient
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)
Effects on myocellular and adipose tissue mRNA expression
Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts
Weight regain
Analysis of body weight regain (BMI; kg/m2) during follow up
Fat mass
Analysis of body fat (kg and %)
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.

Full Information

First Posted
April 14, 2010
Last Updated
December 18, 2017
Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01105143
Brief Title
Effects of Negative Energy Balance on Muscle Mass Regulation
Official Title
Effects of Negative Energy Balance on Muscle Mass Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity, Skeletal Muscle, Insulin Sensitivity/Resistance
Keywords
weight loss, muscle mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle intervention
Arm Type
Active Comparator
Arm Description
Multimodal lifestyle intervention to reduce body weight
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Behavioral
Intervention Name(s)
multimodal lifestyle intervention
Intervention Description
multimodal lifestyle intervention will be performed to reduce body weight
Intervention Type
Behavioral
Intervention Name(s)
placebo
Intervention Description
no intervention, only follow up
Primary Outcome Measure Information:
Title
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)
Time Frame
4 months
Title
Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Analysis of muscle mass (in % of body weight)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Effects on energy expenditure
Description
Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient
Time Frame
4 months
Title
Effects on myocellular and adipose tissue metabolism and substrate utilization
Description
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)
Time Frame
4 months
Title
Effects on myocellular and adipose tissue mRNA expression
Description
Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts
Time Frame
4 months
Title
Weight regain
Description
Analysis of body weight regain (BMI; kg/m2) during follow up
Time Frame
24 months
Title
Fat mass
Description
Analysis of body fat (kg and %)
Time Frame
24 months
Title
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
Description
16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
FFA during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of fatty acids at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Metanephrines during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of metanephrines at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Leptin during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of leptin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Cortisol during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of cortisol at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Follistatin during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of follistatin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Adiponectin during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement adiponectin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Natriuretic peptide during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of natriuretic peptide at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
IGF-1 during negative energy balance and during stabilized modification of body composition after weight loss.
Description
Measurement of IGF-1 at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time Frame
12 months
Title
Analysis of predictive impact of several hormonal and metabolic parameters on body weight regain, course of insulin sensitivity and metabolism
Description
The effect of measured parameters (see other endpoints) on long-term course of BMI, muscle mass, insulin sensitivity and energy expenditure will be analyzed using mathematical models
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI > 27 kg/m2 (adults) postmenopausal state Exclusion criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Mai, Prof
Organizational Affiliation
Charite
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35379337
Citation
Sbierski-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.
Results Reference
derived
PubMed Identifier
29761785
Citation
Koppel 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.
Results Reference
derived

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Effects of Negative Energy Balance on Muscle Mass Regulation

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