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

Phase 1

Completed

• Conditions: Bone and Body Composition; Obesity; Metabolic Syndrome; Physical Function; Quality of Life
• Interventions: Dietary Supplement: Whey protein isolate; Dietary Supplement: Maltodextrin powder supplement

• Registration Number: NCT00912210
• Lead Sponsor: University of Illinois at Urbana-Champaign

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 available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-05
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Last Update Submitted: 2009-05-29
• Study First Posted: 2009-06-03
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher protein	Whey protein isolate	-
Higher carbohydrate	Maltodextrin powder supplement	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline and post 6 months weight loss
Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference	Baseline and post 6 months weight loss
Acid-base balance	Baseline and post 1 and 6 months weight loss
Physical function: balance, gait, strength and activities of daily living	Baseline and post 6 months weight loss

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States