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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Whey protein isolate
* Dietary Supplement: Maltodextrin powder supplement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higher protein<br> | Dietary Supplement: Whey protein isolate<br>* 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)<br>|
| Placebo Comparator: Higher carbohydrate<br> | Dietary Supplement: Maltodextrin powder supplement<br>* 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)<br>* Other names: carbohydrate, starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |