Measuring Eating, Activity and Strength: Understanding the Response -Using Protein

Study Overview
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Brief Summary
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The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from beef. Subject criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)

Official Title
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Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Protein supplementation
* Behavioral: Diet counseling and group education lessons


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60+ yrs. BMI of >30 kg/m2 Body weight <495 lbs. Normal blood chemistries Normal renal function Primary care physician acknowledgement Non-Vegetarian Mild to moderate movement impairment Exclusion Criteria: Body weight >495 pounds. Current smoker. Presence of unstable, acutely symptomatic, or life-limiting illness. Positive screen for dementia using Mini-Cog evaluation tool. Neurological conditions causing functional or cognitive impairments. History of significant weight instability (defined as > 10 pounds weight gain or loss over 6 months prior to study participation). Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months. Inability to walk independently. Bilateral hip replacements. Unable to give consent. Unable to complete written recording forms including journals of eating and exercise behaviors. Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications. Primary Care Physician advises against participation.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weight Loss Control<br>Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%. | Behavioral: Diet counseling and group education lessons<br>* Individual and group diet counseling to achieve a >10% weight loss<br>|
| Experimental: Weight Loss-High Protein<br>Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef. | Dietary Supplement: Protein supplementation<br>* > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery (SPPB) | short physical performance battery | Baseline to 3 to 6 months | 
| Change in lean body mass | Bodpod | Baseline to 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Function, Muscle mass