Metabolic Impact of Dietary Protein Supplementation in Surgical Weight Loss II (MIPS II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Change in Nitrogen balance (NB)
研究概览
简要总结
The obesity epidemic has grown rapidly in the United States, and is associated with increased morbidity and mortality rates. Bariatric surgery (BS) has emerged as the most effective treatment for severe obesity. Surgical weight loss (WL) is very significant (~40-50kg) during the first 6-12 months after surgery. The adequate amount of dietary protein during the active period of surgical weight loss is not known. Dietary protein affects body weight regulation: satiety, thermogenesis, energy efficiency and body composition. During diet-induced energy-restriction, sustaining protein intake (PI) at the level of requirement (0.8g /kg ideal body weight (IBW)/ day) appears to preserve fat free mass (FFM) during active WL. PI above requirements (1.2g protein/Kg IBW/ day) results in favorable body composition changes, with greater decrease in fat mass and preservation of FFM, but without effecting WL. Dietary PI 0.8g/day has been associated with greater satiety and increased energy expenditure (EE) during calorie restriction. In this randomized prospective study, the investigators will evaluate the effect of PI on nitrogen balance, body composition, EE and satiety in 40 women undergoing either Gastric Bypass or Vertical Sleeve Gastrectomy, assigned to high protein supplementation (PRO-S), high PRO-S (1.2g /kg IBW/day) or standard- based current guidelines -PRO-S (0.8g /kg IBW/day). PRO-S will be supplied for 3 months after surgery. Outcome measures including nitrogen balance, body composition changes and satiety will be assessed at pre-surgery, and at 3, 6 and 12 months post-surgery. These results will help provide evidence-based data on safe and optimal levels of protein supplementation after BS
详细描述
The goal of this proposal is to study the effect of dietary protein supplementation (PRO-S) during surgical weight loss, on nitrogen balance, energy expenditure, body composition of weight loss, and satiety. The overall goal is to provide evidence-based data on optimal levels of protein supplementation after surgical weight loss by gastric bypass (GBP), a restrictive and malabsorptive procedure, or by vertical sleeve gastrectomy (VSG), a purely restrictive procedure.
We propose a prospective randomized controlled trial (RCT), in which, patients undergoing either GBP or VSG will be allocated to standard PRO-S recommendation ("standard care" according to the American Society for Metabolic and Bariatric Surgery Guidelines) or high supplementation. We will compare 4 groups of subjects:
- Group 1: GBP Standard PRO-S (0.8g protein/kg ideal body weight (IBW)/day
- Group 2: GBP High PRO-S (1.2g protein/ kg ideal body weight (IBW)/ day)
- Group 3: VSG Standard PRO-S (0.8g protein/kg ideal body weight (IBW)/day
- Group 4: VSG High PRO-S (1.2g protein/ kg ideal body weight (IBW)/ day)
AIM#1: Measure total body nitrogen balance (NB) to assess adequacy of levels of protein intake and protein absorption.
AIM#2: Measure the effect PRO-S on lean body mass (LBM), and resting energy expenditure (REE).
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled to undergo either GBP or VSG.
- •Ethnicity/gender: People of all race/ethnicity are eligible to participate, so that the study will reflect a diverse population.
- •Non diabetic or diet controlled diabetic with no medication
排除标准
- •Individuals who have a clinical history strongly suggestive of type 1 diabetes mellitus or T2DM will be excluded.
- •Nitrogen retention disease such as renal or hepatic disease.
- •Known malabsorption syndrome.
- •Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
研究组 & 干预措施
GBP-SPS
GBP Standard PRO-S (0.8g protein/kg ideal body weigh/day)
干预措施: GBP-SPS (Dietary Supplement)
GBP-HPS
GBP High PRO-S (1.2g protein/ kg ideal body weight/ day)
干预措施: GBP-HPS (Dietary Supplement)
VSG-SPS
VSG Standard PRO-S (0.8g protein/kg ideal body weigh/ day)
干预措施: VSG-SPS (Dietary Supplement)
VSG-HPS
VSG High PRO-S (1.2g protein/ kg ideal body weight/ day)
干预措施: VSG-HPS (Dietary Supplement)
结局指标
主要结局
Change in Nitrogen balance (NB)
时间窗: Change form 3 month to 12 months
During inpatient stay. Nitrogen intake and output will be accurately monitored
Change in Nitrogen Balance
时间窗: Change from baselina to 12 months
During inpatient stay. Nitrogen intake and output will be accurately monitored
次要结局
- Satiety scores(0, 3 and 12 months)
- Composite outcome measure consisting of Lean body mass (LBM), and resting energy expenditure (REE).(0, 3 and 12 months after surgery)
- Adherence score to protein supplementation.(0, 3 and 12 months)
研究者
Blandine Laferrere
Associate professor of medicine
Columbia University
