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Effects of Negative Energy Balance on Muscle Mass Regulation

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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