NCT00912210已完成1 期
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index > 28 kg/m²
- •Clearance of primary physician to participate in diet and mild exercise
排除标准
- •Medical condition contraindicating prescribed diet and exercise regimen
- •Type 2 Diabetes Mellitus
- •Physically active lifestyle (>30 min moderate physical activity 2+ times weekly)
结局指标
主要结局
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
时间窗: Baseline and post 6 months weight loss
次要结局
- 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)
- Physical function: balance, gait, strength and activities of daily living(Baseline and post 6 months weight loss)
研究者
研究点 (2)
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