Optimization of Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training: Interventional Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Changes in fat-free mass at 6 months
研究概览
简要总结
The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect
详细描述
Design: Open randomised controlled trial comparing, in obese patients after GBP, an additional oral intake of protein with or without a muscular-strengthening physical training programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as control (3 groups). Primary outcome: Variation at 6 months after GBP in total and appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of the study: 36 months. Duration of participation for one patient: 7 months. Number of centers: Monocentric study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age between 18 and 60 years
- •Planned obesity treatment by gastric bypass
- •Written informed consent
排除标准
- •Subject not affiliated with a social security scheme
- •Regular follow-up not feasible
- •Participation in a structured physical activity program
- •Recent coronary event
- •Uncontrolled hypertension
- •proliferative diabetic retinopathy or disabling neuropathy, treatment by dialysis, orthopedic problems
- •Pregnancy
- •Specific food intolerance to protein products
- •Abnormal cardiac stress test
结局指标
主要结局
Changes in fat-free mass at 6 months
时间窗: 6 months
次要结局
- Variation at 6 months after GBP in quality of life and obesity co-morbidities(6 months)
- Variation at 6 months after GBP in muscular strength and habitual physical activity(6 months)
- Variation at 6 months after GBP of other body composition components(6 months)
- Variation at 6 months after GBP in dietary habits(6 months)
- Variation at 6 months after GBP in obesity-associated inflammatory markers(6 months)