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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912210
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
University of Illinois at Urbana-Champaign

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bone and Body Composition Obesity Metabolic Syndrome Physical Function Quality of Life Dietary Supplement: Whey protein isolate Dietary Supplement: Maltodextrin powder supplement Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Study Start Date : April 2009

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Arms and Interventions
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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 Name: carbohydrate, starch


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912210


Locations
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United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Ellen M Evans, PhD University of Illinois at Urbana-Champaign
Principal Investigator: Donald K Layman, PhD University of Illinois at Urbana-Champaign
Principal Investigator: Edward McAuley, PhD University of Illinois at Urbana-Champaign
More Information
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Responsible Party: Ellen Evans, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT00912210    
Other Study ID Numbers: UIUC IRB 07782
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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Metabolic Syndrome
Weight Loss
Body Weight Changes
Body Weight
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases