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

This study has been completed.
Sponsor:
Information provided by:
University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT00912210
First received: May 29, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois at Urbana-Champaign:

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 [ Time Frame: Baseline and post 6 months weight loss ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical function: balance, gait, strength and activities of daily living [ Time Frame: Baseline and post 6 months weight loss ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline and post 6 months weight loss ] [ Designated as safety issue: No ]
  • Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference [ Time Frame: Baseline and post 6 months weight loss ] [ Designated as safety issue: No ]
  • Acid-base balance [ Time Frame: Baseline and post 1 and 6 months weight loss ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: April 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912210

Locations
United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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

No publications provided

Responsible Party: Ellen Evans, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT00912210     History of Changes
Other Study ID Numbers: UIUC IRB 07782
Study First Received: May 29, 2009
Last Updated: May 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013