Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery, a Randomized Double-blind Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Fat Free mass loss
研究概览
简要总结
This double blind randomized placebo controlled trial investigates the effect of protein supplementation on fat free mass loss in patients who underwent a Roux-en-Y gastric bypass.
详细描述
Rationale: Protein malnutrition is a severe complication of bariatric surgery and leads to increased morbidity. Previous studies have shown that protein intake and physical activity are the most important factors in the preservation of fat free mass during weight loss. Low protein intake is very common in patients undergoing bariatric surgery despite dietary counselling. Protein powder supplements might help patients to achieve the protein intake recommendations after bariatric surgery and could therefore contribute to preserve fat free mass.
Objective: The main aim of this study is to assess the effect of a daily consumed clear protein powder shake during the first six months after bariatric surgery on fat free mass loss in the first twelve months after laparoscopic Roux-en-Y gastric bypass (LRYGB).
Study design: Double-blind randomized placebo-controlled intervention study
Study population: Patients undergoing LRYGB at the bariatric expertise center for obesity of the Maasstad Hospital Rotterdam.
Intervention and procedure: Inclusion will take place at the outpatient clinic of the bariatric expertise center for obesity of the Maasstad Hospital. Patients will be randomly assigned to either the intervention or control group before surgery. The intervention group will receive a clear protein powder shake of 200 ml containing 20 grams of whey protein which should be taken daily during the first six months after LRYGB. The control group will receive an isocaloric, clear, placebo shake containing maltodextrine.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study products (protein or placebo drinks) are provided to study participants. Study product is marked by a unique batch number, corresponding to protein or placebo in the ingredients list.
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
- 否
入选标准
- •- Scheduled for a laparoscopic Roux-en-Y Gastric Bypass
- •Age 18 - 65 years
- •Body Mass Index ≥ 35 with the presence of severe comorbidity related to morbid obesity (diabetes mellitus type 2, obstructive sleep apnoea syndrome (OSAS), hypertension, etc.) or a BMI ≥ 40 with or without the presence of severe comorbidity related to morbid obesity
- •Written informed consent
排除标准
- •- Revisional bariatric surgery
- •A protein-restricted diet for medical reasons
- •Diagnosis of a (neuro-) muscular disease
- •Inability to undergo MF-BIA (i.e. pregnancy, pacemaker)
- •Allergy to any of the ingredients of either the protein or the placebo shake
研究组 & 干预措施
Protein
Daily protein shake during 6 months after surgery
干预措施: Protein drink supplementation (Dietary Supplement)
Control
Daily placebo shake during 6 months after surgery
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Fat Free mass loss
时间窗: Change of fat free mass at 6 months post surgery compared to pre surgery
Main study endpoint is percentage fat free mass loss at 6 months defined as fat free mass loss (kg) divided by total weight loss (kg) x 100%. Fat free mass will be assessed using the Seca® MBCA 515, which is a multi-frequency bio-electrical impedance analysis (MF-BIA). MF-BIA is an easy and non-invasive measurement tool and has been validated in morbid obese patients (13, 14). BIA measurements will be conducted under standardized circumstances. Patients can wear light clothes, have to empty their pockets and have to have an empty bladder. Patients will be asked to have no intensive physical activity and to have no food and fluid intake two hours prior to the measurements to minimalize bias.
次要结局
- fat mass loss,(Change of fat mass at 6 months post surgery compared to pre surgery)
- hand grip strength,(Change of hand grip strength at 6 months post surgery compared to pre surgery)
- percentage of fat free mass loss,(Change of percentage fat free mass at 6 months post surgery compared to pre surgery)
- BMI(Change of BMI at 6 months post surgery compared to pre surgery)
- total weight loss,(pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
- total protein intake(Change of total protein intake at 6 months post surgery compared to pre surgery)