Back to resultsHigher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Primary Purpose
Bone and Body Composition, Obesity, Metabolic Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Whey protein isolate
Maltodextrin powder supplement
Sponsored by
About this trial
This is an interventional basic science trial for Bone and Body Composition
Eligibility 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)
Sites / Locations
- University of Illinois at Urbana-Champaign
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Higher protein
Higher carbohydrate
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Physical function: balance, gait, strength and activities of daily living
Quality of life
Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference
Acid-base balance
Full Information
NCT ID
NCT00912210
First Posted
May 29, 2009
Last Updated
May 29, 2009
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT00912210
Brief Title
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Official Title
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone and Body Composition, Obesity, Metabolic Syndrome, Physical Function, Quality of Life
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Higher protein
Arm Type
Active Comparator
Arm Title
Higher carbohydrate
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein isolate
Intervention Description
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
Intervention Name(s)
Maltodextrin powder supplement
Other Intervention Name(s)
carbohydrate, starch
Intervention Description
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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Physical function: balance, gait, strength and activities of daily living
Time Frame
Baseline and post 6 months weight loss
Title
Quality of life
Time Frame
Baseline and post 6 months weight loss
Title
Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference
Time Frame
Baseline and post 6 months weight loss
Title
Acid-base balance
Time Frame
Baseline and post 1 and 6 months weight loss
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen M Evans, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald K Layman, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward McAuley, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
12. IPD Sharing Statement
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Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
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