Effects of Negative Energy Balance on Muscle Mass Regulation

Not Applicable

Completed

• Conditions: Insulin Sensitivity/Resistance; Weight Loss; Obesity; Skeletal Muscle
• Interventions: Behavioral: placebo; Behavioral: multimodal lifestyle intervention

• Registration Number: NCT01105143
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Study Start: 2012-03
• Primary Completion: 2015-05
• Study Completion: 2017-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
lifestyle intervention	multimodal lifestyle intervention	Multimodal lifestyle intervention to reduce body weight

Primary Outcome Measures

Name	Time	Method
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.	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.	4 months	Analysis of muscle mass (in % of body weight)

Secondary Outcome Measures

Name	Time	Method
Weight regain	24 months	Analysis of body weight regain (BMI; kg/m2) during follow up
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	4 months	16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances.
Effects on energy expenditure	4 months	Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient
Fat mass	24 months	Analysis of body fat (kg and %)
Effects on myocellular and adipose tissue mRNA expression	4 months	Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts
Effects on myocellular and adipose tissue metabolism and substrate utilization	4 months	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)

Trial Locations

Locations (1)

Charite; 🇩🇪 Berlin, Germany