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

NCT00912210 | Completed Phase 1

• 1 other identifier: UIUC IRB 07782
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Physical function: balance, gait, strength and activities of daily living

  Baseline and post 6 months weight loss

• 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

Study Arms (2)

Higher protein

ACTIVE COMPARATOR

Dietary Supplement: Whey protein isolate

Higher carbohydrate

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin powder supplement

Interventions

Whey protein isolate DIETARY_SUPPLEMENT

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)

Higher protein

Maltodextrin powder supplement DIETARY_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)

Also known as: carbohydrate, starch

Higher carbohydrate

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index \> 28 kg/m²
• Clearance of primary physician to participate in diet and mild exercise

You may not qualify if:

• Medical condition contraindicating prescribed diet and exercise regimen
• Type 2 Diabetes Mellitus
• Physically active lifestyle (\>30 min moderate physical activity 2+ times weekly)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Carbohydrates; Starch

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Polysaccharides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 3, 2009
• Study Start: April 1, 2009
• Last Updated: June 3, 2009

Record last verified: 2009-05

Locations

US (1)