Effects of Negative Energy Balance on Muscle Mass Regulation
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
- Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
研究概览
简要总结
The investigators here propose to perform a prospective randomized intervention trial in post-menopausal women to investigate the endocrine network, which contributes to the changes in skeletal muscle mass during weight loss.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI > 27 kg/m2 (adults)
- •postmenopausal state
- •Exclusion criteria:
- •weight loss of more than 5kg in the last 2 months x
- •unhealthy patients with: severe chronic diseases including cancer within the last 5 years, severe heart disease, severe impairment of hepatic or renal function, severe anaemia or disturbed coagulation
- •eating disorders or any other psychiatric condition that would interact with the trial intervention
- •malabsorption
- •acute or chronic infections
- •severe hypertension
- •food allergies
- •any other uncontrolled endocrine disorder
- •changes of smoking habits, diets or medication that strongly affects energy homeostasis within the last 3 months prior to study inclusion
排除标准
- 未提供
研究组 & 干预措施
lifestyle intervention
Multimodal lifestyle intervention to reduce body weight
干预措施: multimodal lifestyle intervention (Behavioral)
placebo
placebo
干预措施: placebo (Behavioral)
结局指标
主要结局
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
时间窗: 4 months
Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)
Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
时间窗: 4 months
Analysis of muscle mass (in % of body weight)
次要结局
- Measurement of human gut microbiome at baseline, during weight loos, after weight loss (negative energy balance) and during stabilized modification of body composition 4 weeks after weight loss(4 months)
- Effects on energy expenditure(4 months)
- Fat mass(24 months)
- Effects on myocellular and adipose tissue mRNA expression(4 months)
- Effects on myocellular and adipose tissue metabolism and substrate utilization(4 months)
- Weight regain(24 months)
研究者
Professor Joachim Spranger
Professor
Charite University, Berlin, Germany