Randomized, Pilot Study to Compare the Effects of a Novel Dietary Intervention With the Post-operative Standard of Care on Body Composition After Laparoscopic Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Total and extracellular water (by cold bromide and deuterium method)
研究概览
简要总结
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.
详细描述
STUDY SUMMARY The purpose of this pilot study is to compare a medical food intervention with the dietary standard of care at Boston Medical Center, in obese women subjects undergoing Roux-en Y gastric bypass surgery. Commercially available nutritional supplements will also be provided as part of the study's protocol.
Subjects will be selected from surgical candidates of the Nutrition and Weight Management Center who meet the study criteria. Subjects will be randomly assigned to one of the 2 groups (treatment and control). Subjects will be seen at the study site 2 weeks before surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5 visits). Data recorded during the study visits will be used to assess post-operative progress and will include: body composition, resting energy expenditure, muscle strength, quality of life questionnaires, hair loss, and blood markers for insulin resistance, nutritional state, organ function, lipid profile and inflammation. Safety indicators and compliance will also be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese and morbidly obese women (BMI 30 - 50)
- •25 years and older undergoing laparoscopic gastric bypass surgery
- •Present with at least either metabolic syndrome or diabetes
排除标准
- •Have smoked in the past 4 weeks
- •Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA)
- •There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study
结局指标
主要结局
Total and extracellular water (by cold bromide and deuterium method)
时间窗: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Dual energy X-ray absorptiometry (DEXA)
时间窗: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
次要结局
- Hair loss (by photographic method and Hair-Scalp Questionnaire)(Baseline, 12 weeks, and 24 weeks)
- Impedance plethysmography (by distal and proximal electrode placement)(Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks)
- Muscle strength (by a handgrip dynamometer)(Baseline, 4weeks, 12 weeks, and 24 weeks)
- Resting energy expenditure (by indirect calorimetry)(Baseline, 4 weeks, 12 weeks and 24 weeks)
- Pulse after a 6-minute walk(Baseline, 4 weeks, 12 weeks, and 24 weeks)
- Measures of insulin resistance, visceral protein/nutritional status, and inflammation(Baseline, 12 weeks, and 24 weeks)