Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in Short Physical Performance Battery (SPPB)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Weight Loss Control
Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
干预措施: Diet counseling and group education lessons (Behavioral)
Weight Loss-High Protein
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.
干预措施: Protein supplementation (Dietary Supplement)
结局指标
主要结局
Change in Short Physical Performance Battery (SPPB)
时间窗: Baseline to 3 to 6 months
short physical performance battery
Change in lean body mass
时间窗: Baseline to 3 and 6 months
Bodpod
次要结局
未报告次要终点