An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change in muscle quality
研究概览
简要总结
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from dairy and other animal source proteins) with calorie restriction and low-intensity exercise on muscle quality and muscle adipose infiltration (along with bone mineral density [BMD] and a number of secondary outcomes) in frail, obese, older adults participating in a 6 month intervention. The investigators will compare these effects to those of a traditional control regimen of calorie restriction and low-intensity exercise over the same duration.
详细描述
Obese older adults (≥60 yrs) with moderate functional impairment will be randomized to 1 of 2 study arms. Outcomes to be measured at 0, 3 and 6 months are as follows: Primary outcomes- (1) Muscle Quality (MQ): muscle power (time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity) in relation to muscle mass (CT-scan) and (2) Muscle adipose infiltration (MAI) (CT-scan). Secondary outcomes- Bone Mineral Density (BMD; DXA scan) physical function (Short Physical Performance Battery (SPPB); 6 minute walk; 8-foot up and go; and 30 second chair stands; handgrip strength; body weight; fat mass; waist circumference; activity (accelerometers); mental health (sleep, depression, quality of life); and feasibility factors (adherence, protein intake, nutrition adequacy). BMD will only be accessed at 0 and 6 months.
Study Arms:
- Weight loss plus low-intensity exercise intervention (WL-LoEX; n = 35): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly. One serving of dairy protein/day will be provided to WL-LoEX participants.
- High protein weight loss plus low-intensity exercise intervention (PRO-WL-LoEX; n = 35): 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 protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from dairy foods that will be provided. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •BMI >30;
- •SPPB score of ≥4 to <10;
- •GFR <45 mL/min
排除标准
- •Body weight >495 lbs. (BodPod limits);
- •estimated glomerular filtration rates (eGFR) less than 45 mL/min;
- •symptomatic cardiac disease;
- •receiving chemotherapy;
- •hemophilia;
- •presence of unstable or symptomatic life-threatening illness;
- •neurological disease or disorder causing functional impairments;
- •inability to walk,
- •dementia;
- •prescription weight loss medications;
- •use of monamine oxidase inhibitors (MAOIs); or
- •primary medical provider advises against participation.
研究组 & 干预措施
WL-LoEX
10% Weight loss diet plus low intensity exercise (protein ~0.8g/kg). Participants will be provided one serving of dairy protein daily.
干预措施: Weight Loss (Behavioral)
WL-LoEX
10% Weight loss diet plus low intensity exercise (protein ~0.8g/kg). Participants will be provided one serving of dairy protein daily.
干预措施: Dairy Protein (Dietary Supplement)
WL-LoEX
10% Weight loss diet plus low intensity exercise (protein ~0.8g/kg). Participants will be provided one serving of dairy protein daily.
干预措施: Low intensity exercise (Behavioral)
Pro-WL-LoEX
Protein-enhanced 10% Weight loss diet plus low intensity exercise (protein ~1.2 g/kg with > 30g per meal and >60% as dairy). Participants will be provided at least 8 servings of dairy protein daily.
干预措施: Weight Loss (Behavioral)
Pro-WL-LoEX
Protein-enhanced 10% Weight loss diet plus low intensity exercise (protein ~1.2 g/kg with > 30g per meal and >60% as dairy). Participants will be provided at least 8 servings of dairy protein daily.
干预措施: Dairy Protein (Dietary Supplement)
Pro-WL-LoEX
Protein-enhanced 10% Weight loss diet plus low intensity exercise (protein ~1.2 g/kg with > 30g per meal and >60% as dairy). Participants will be provided at least 8 servings of dairy protein daily.
干预措施: Low intensity exercise (Behavioral)
结局指标
主要结局
Change in muscle quality
时间窗: baseline, 3 months, 6 months
composite score of time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity in relation to muscle mass
Change in muscle adipose infiltration
时间窗: baseline, 3 months, 6 months
CT-scan
次要结局
- Change in dietary protein intake(baseline, 3 months, 6 months)
- Change in calorie intake(baseline, 3 months, 6 months)
- Change in Bone Mineral Density(Baseline and 6-months)
- Change in sleep(baseline, 3 months, 6 months)
- Change in depression(baseline, 3 months, 6 months)
- Change in 8-foot up and go time(baseline, 3 months, 6 months)
- Change in hand grip strength(baseline, 3 months, 6 months)
- Change in 30 second chair stands(baseline, 3 months, 6 months)
- Change in Physical Function(baseline, 3 months, 6 months)
- Change in Body weight(baseline, 3 months, 6 months)
- Change in 6-minute walk time(baseline, 3 months, 6 months)
- Change in physical activity(Baseline, 3 months, 6 months)
- Change in quality of life(Baseline, 3 months, 6 months)
- Change in lean Body Mass(baseline, 3 months, 6 months)
- Change in fat mass(baseline, 3 months, 6 months)