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

May 29, 2009 updated by: University of Illinois at Urbana-Champaign
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois at Urbana-Champaign

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Higher protein
Dietary supplement: 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)
Placebo Comparator: Higher carbohydrate
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)
Other Names:
  • carbohydrate, starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone and body composition: Weight, percent fat, muscle and fat distribution in the thigh and abdomen and bone density and structural quality assessed by DXA and structural MRI
Time Frame: Baseline and post 6 months weight loss
Baseline and post 6 months weight loss

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical function: balance, gait, strength and activities of daily living
Time Frame: Baseline and post 6 months weight loss
Baseline and post 6 months weight loss
Quality of life
Time Frame: Baseline and post 6 months weight loss
Baseline and post 6 months weight loss
Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference
Time Frame: Baseline and post 6 months weight loss
Baseline and post 6 months weight loss
Acid-base balance
Time Frame: Baseline and post 1 and 6 months weight loss
Baseline and post 1 and 6 months weight loss

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
  • Principal Investigator: Ellen M Evans, PhD, University of Illinois at Urbana-Champaign
  • Principal Investigator: Donald K Layman, PhD, University of Illinois at Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIUC IRB 07782

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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