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Effects of Negative Energy Balance on Muscle Mass Regulation

NCT ID: NCT01105143

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Weight Loss Obesity Skeletal Muscle Insulin Sensitivity/Resistance

Keywords

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weight loss muscle mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lifestyle intervention

Multimodal lifestyle intervention to reduce body weight

Group Type ACTIVE_COMPARATOR

multimodal lifestyle intervention

Intervention Type BEHAVIORAL

multimodal lifestyle intervention will be performed to reduce body weight

placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BEHAVIORAL

no intervention, only follow up

Interventions

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multimodal lifestyle intervention

multimodal lifestyle intervention will be performed to reduce body weight

Intervention Type BEHAVIORAL

placebo

no intervention, only follow up

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Professor Joachim Spranger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Knut Mai, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite

Locations

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Charite

Berlin, , Germany

Site Status

Countries

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Germany

References

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Spranger L, Weiner J, Bredow J, Zeitz U, Grittner U, Boschmann M, Dickmann S, Stobaus N, Schwartzenberg RJ, Brachs M, Spranger J, Mai K. Thrifty energy phenotype predicts weight regain in postmenopausal women with overweight or obesity and is related to FGFR1 signaling. Clin Nutr. 2023 Apr;42(4):559-567. doi: 10.1016/j.clnu.2023.02.020. Epub 2023 Feb 24.

Reference Type DERIVED
PMID: 36863292 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35379337 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29761785 (View on PubMed)

Other Identifiers

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EA 20100415

Identifier Type: -

Identifier Source: org_study_id