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临床试验/NCT02128698
NCT02128698已完成不适用

Physical Activity and Protein Supplementation After Bariatric Surgery

University of Hohenheim2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Lean body mass loss expressed as percentage of weight loss [%]

研究概览

简要总结

The purpose of this study is to determine wether regular physical activity in combination with protein supplementation after bariatric surgery can reduce the loss of muscle mass and wether a computer-assisted exercise program is more effective than a usual exercise program regarding frequency of physical activity, fitness and muscular strength.

详细描述

Bariatric surgery has become a major treatment option for severe obesity in adults. Despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. Postoperative risks include protein deficiency and pronounced muscle mass loss. Indeed, numerous studies indicate a significant reduction in lean body mass resulting from protein deficiency after bariatric surgery.

Dietary proteins have shown to play an important role in body weight regulation. A protein-rich diet attains satiety and thereby facilitates reduction in overall energy intake. It has also shown to enhance food-induced thermogenesis. Furthermore, a protein-rich diet - ideally in combination with exercise - preserves lean body mass and thus resting energy expenditure leading to an improvement of long-term energy balance. Therefore, protein-rich diets or protein supplements, respectively, might facilitate weight loss, especially body fat loss and protect against loss in muscle mass in patients who underwent bariatric surgery. The aim of the present randomized, placebo-controlled, double blind pilot study was to test the possible benefit of proteins in combination with exercise in patients undergoing bariatric surgery, and to examine, whether computer-assisted exercise is advantageous when comparing it to a usual exercise program using written exercise instructions. Therefore, we study the influence of postoperative protein supplementation in combination with computer-assisted exercise on body composition changes, and body weight reduction, as well as physical fitness, protein status and muscle function in obese patients after bariatric surgery.

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, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 18 - 65 years
  • Body weight of ≤ 150 kg
  • BMI > 35 kg/m2
  • Indication for laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. The decision about the type of surgery is performed independent of the study by the surgeons in charge according to the German S3 guideline.

排除标准

  • Kidney diseases of any kind
  • Serious gastrointestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa, etc.)
  • Serious musculoskeletal diseases
  • Serious heart diseases (Myocardial infarction, stent implantation, stroke, etc.)
  • Intake of blood thinning medicine (e.g. ASS, Marcumar, etc.)

结局指标

主要结局

Lean body mass loss expressed as percentage of weight loss [%]

时间窗: At month 6

Lean body mass is measured by using body impedance analysis. The content of lean body mass in lost weight is calculated using the lost weight in kg and the lost lean body mass in kg.

次要结局

  • Relative weight loss [%](At month 6)
  • Grip strength endurance [sec](At month 6)
  • Physical fitness [repetitions per 30 sec] / [distance in meters](At month 6)
  • Grip strength [lb](At month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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