Effects of Negative Energy Balance on Muscle Mass Regulation

Charité University Medicine Berlin

Status: Completed

Conditions: Weight Loss; Insulin Sensitivity/Resistance; Obesity; Skeletal Muscle

Treatments: Behavioral: multimodal lifestyle intervention; Behavioral: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01105143

EA 20100415

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups, including a placebo group

lifestyle intervention

Active Comparator group

Description:

Multimodal lifestyle intervention to reduce body weight

Treatment:

Behavioral: multimodal lifestyle intervention

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Behavioral: placebo