A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Change in whole-body and appendicular lean mass
研究概览
简要总结
Despite the importance of preventing muscle mass loss during senescence, only a few studies have investigated the relationship between diet and muscle mass in postmenopausal women. Therefore, the aim of this study is to investigate whether controlled protein consumption at the current Recommended Daily Allowance (RDA = 0.8 g/kg body weight) or twice the RDA (1.6 g/kg body weight) affects skeletal muscle mass, strength, and physical performance in postmenopausal women. In this parallel-group trial, participants were randomized for 6 months to low glycemic index diets with controlled protein consumption at the current RDA or twice the RDA, aimed to balance energy needs.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women
- •Without mobility aids, able to perform activities of daily living independently
排除标准
- •Use of hormone therapy in the past 3 months
- •Insulin therapy
- •Previous diagnosis of heart disease
- •Untreated thyroid diseases
- •Conditions affecting neuromuscular function
结局指标
主要结局
Change in whole-body and appendicular lean mass
时间窗: 6 months
measured by dual-energy X-ray absorptiometry
次要结局
- Change in diastolic blood pressure(6 months)
- Change in fat mass(6 months)
- Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides(6 months)
- Change in glucose(6 months)
- Change in systolic blood pressure(6 months)
- Change in resting metabolic rate(6 months)
- Change in isometric hand grip strength(6 months)
- Change in usual gait speed(6 months)
- Change in high-sensitivity C-reactive protein(6 months)
- Change in insulin(6 months)