Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Weight Loss
- Sponsor
- Duke University
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Change in Short Physical Performance Battery (SPPB)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Short Physical Performance Battery (SPPB)
Time Frame: Baseline to 3 to 6 months
short physical performance battery
Change in lean body mass
Time Frame: Baseline to 3 and 6 months
Bodpod