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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912210
• Other study ID #: UIUC IRB 07782
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2009
• Last updated: May 29, 2009
• Start date: April 2009

Study information

• Verified date: May 2009
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bone and Body Composition
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Physical Function
• Quality of Life

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline and post 6 months weight loss	No
Secondary	Physical function: balance, gait, strength and activities of daily living		Baseline and post 6 months weight loss	No
Secondary	Quality of life		Baseline and post 6 months weight loss	No
Secondary	Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference		Baseline and post 6 months weight loss	No
Secondary	Acid-base balance		Baseline and post 1 and 6 months weight loss	No