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OpenTrials
Completed

NCT Number: NCT00912210

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

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.

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Key information

Conditions

Bone and Body Composition Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Function Quality of Life Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

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)

Other names: carbohydrate, starch

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

    Time frame: Baseline and post 6 months weight loss

Secondary outcomes

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

    Time frame: Baseline and post 6 months weight loss

  2. Quality of life

    Time frame: Baseline and post 6 months weight loss

  3. Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference

    Time frame: Baseline and post 6 months weight loss

  4. Acid-base balance

    Time frame: Baseline and post 1 and 6 months weight loss

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Important dates

Study start
2009
First posted
Jun 3, 2009
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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