Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women

NCT ID: NCT00912210

Last Updated: 2009-06-03

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

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight women over age 60.

Detailed Description

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Conditions

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Bone and Body Composition Obesity Metabolic Syndrome Physical Function Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Higher protein

Group Type ACTIVE_COMPARATOR

Whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50g/day (two 25 g doses taken at breakfast and afternoon snack mixed with food or beverage)

Higher carbohydrate

Group Type PLACEBO_COMPARATOR

Maltodextrin powder supplement

Intervention Type DIETARY_SUPPLEMENT

Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50 g / day (two 25 g doses at breakfast and afternoon snack mixed with food or beverage)

Interventions

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Whey protein isolate

Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50g/day (two 25 g doses taken at breakfast and afternoon snack mixed with food or beverage)

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin powder supplement

Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50 g / day (two 25 g doses at breakfast and afternoon snack mixed with food or beverage)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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carbohydrate, starch

Eligibility Criteria

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Inclusion Criteria

* Body mass index \> 28 kg/m²
* Clearance of primary physician to participate in diet and mild exercise

Exclusion Criteria

* Medical condition contraindicating prescribed diet and exercise regimen
* Type 2 Diabetes Mellitus
* Physically active lifestyle (\>30 min moderate physical activity 2+ times weekly)
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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University of Illinois at Urbana-Champaign

Principal Investigators

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Ellen M Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Donald K Layman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Edward McAuley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

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University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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UIUC IRB 07782

Identifier Type: -

Identifier Source: org_study_id

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