Clinical trial NCT01105143: Effects of Negative Energy Balance on Muscle Mass Regulation
Official title: Effects of Negative Energy Balance on Muscle Mass Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Skeletal Muscle
Insulin Sensitivity/Resistance
Keywords: weight loss
muscle mass
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2010-04-16
Enrollment: 81
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 4 months
measure: Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 4 months
Secondary outcomes:
measure: Effects on energy expenditure
timeFrame: 4 months
measure: Effects on myocellular and adipose tissue metabolism and substrate utilization
timeFrame: 4 months
measure: Effects on myocellular and adipose tissue mRNA expression
timeFrame: 4 months
measure: Weight regain
timeFrame: 24 months
measure: Fat mass
timeFrame: 24 months
measure: 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
timeFrame: 4 months
Other outcomes:
measure: FFA during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Metanephrines during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Leptin during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Cortisol during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Follistatin during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Adiponectin during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Natriuretic peptide during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: IGF-1 during negative energy balance and during stabilized modification of body composition after weight loss.
timeFrame: 12 months
measure: Analysis of predictive impact of several hormonal and metabolic parameters on body weight regain, course of insulin sensitivity and metabolism
timeFrame: 24 months
Locations:
city: Berlin
country: Germany
facility: Charite
Study officials:
affiliation: Charite
name: Knut Mai, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.