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Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly

NCT ID: NCT00779207

Last Updated: 2008-10-24

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

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to determine the effect of weight loss and exercise on liver and muscle fat.

Detailed Description

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Obesity causes serious medical complications and impairs quality of life. Moreover, both aging and obesity cause metabolic and physical dysfunction. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on Intrahepatic and Intramyocellular fat in obese elderly men and women. The central hypothesis is that in obese elderly subjects, weight loss will improve metabolic and physical function while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 20 elderly (65-85 years old) obese men and women (body mass index \[BMI\] \> 30 kg/m2) with physical frailty will be randomized to 2 treatment groups: 1)10% weight loss, 2) 10% weight loss plus exercise training.

Conditions

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Obesity

Keywords

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obesity aging exercise diet weight loss physical function Obesity in the Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

weight loss

Group Type EXPERIMENTAL

weight loss

Intervention Type BEHAVIORAL

10 percent weight loss through diet and behavioral modification

2

Weight loss and exercise

Group Type EXPERIMENTAL

weight loss and exercise

Intervention Type BEHAVIORAL

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Interventions

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weight loss and exercise

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Intervention Type BEHAVIORAL

weight loss

10 percent weight loss through diet and behavioral modification

Intervention Type BEHAVIORAL

Other Intervention Names

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lifestyle modification lifestyle change

Eligibility Criteria

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Inclusion Criteria

* Obese (BMI 30 or greater)
* Elderly (age 65 years or older)

Exclusion Criteria

* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Washington University School of Medicine

Principal Investigators

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Dennis T Villareal, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.

Reference Type BACKGROUND
PMID: 15229329 (View on PubMed)

Other Identifiers

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R01AG025501

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK 37948A

Identifier Type: -

Identifier Source: org_study_id