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

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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

Tracking Information
First Submitted Date  ICMJE May 29, 2009
First Posted Date  ICMJE June 3, 2009
Last Update Posted Date June 3, 2009
Study Start Date  ICMJE April 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
  • Physical function: balance, gait, strength and activities of daily living [ Time Frame: Baseline and post 6 months weight loss ]
  • Quality of life [ Time Frame: 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 ]
  • Acid-base balance [ Time Frame: Baseline and post 1 and 6 months weight loss ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Official Title  ICMJE Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Bone and Body Composition
  • Obesity
  • Metabolic Syndrome
  • Physical Function
  • Quality of Life
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Active Comparator: Higher protein
    Intervention: Dietary Supplement: Whey protein isolate
  • Placebo Comparator: Higher carbohydrate
    Intervention: Dietary Supplement: Maltodextrin powder supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2009)
31
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912210
Other Study ID Numbers  ICMJE UIUC IRB 07782
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ellen Evans, Associate Professor, University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE University of Illinois at Urbana-Champaign
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Illinois at Urbana-Champaign
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP