Calorie Restriction With Leucine Supplementation in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in bone mineral density and bone mineral content
研究概览
简要总结
The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Obese with body mass index (BMI) between 30 and 40 kg/m2
- •Postmenopausal
- •Sedentary (i.e., less than 1.5 hours of exercise per week)
排除标准
- •Individuals with diabetes and/or uncontrolled hypertension
- •Individuals with hepatitis B and/or C
- •Individuals who smoke
- •Individuals with an allergy to whey protein
结局指标
主要结局
Change in bone mineral density and bone mineral content
时间窗: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).
Change in muscle strength
时间窗: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.
Change in muscle mass
时间窗: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
We will measure total appendicular skeletal muscle mass by using dual-energy X-ray absorptiometry (DXA) and thigh muscle volume by magnetic resonance imaging (MRI)
次要结局
- Change in bacterial populations found in the stool(Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group)
- Change in cell proliferation (growth) rates in the colon(Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group)
- Change in skeletal muscle insulin sensitivity(Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group)
- Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity(Prior to starting the weight loss or maintenance intervention)
- Determine the acute effect of leucine ingestion on muscle protein metabolism(Prior to starting the weight loss or maintenance intervention)