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临床试验/NCT02001636
NCT02001636已完成不适用

Impact of Protein Supplementation After Bariatric Surgery - a Randomized, Controlled, Double Blind Pilot Study

University of Hohenheim1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Excess weight loss [%]

研究概览

简要总结

Obese patients, who underwent bariatric surgery, are at risk to develop protein malnutrition. The aim of this study is to evaluate the influence of postoperative protein supplementation on weight reduction, body composition and protein status.

详细描述

Bariatric surgery has become a major treatment option for severe obesity in adults. It has proven its efficiency regarding weight loss and its benefits concerning the improvement or even remission of obesity related comorbidities. Additionally, bariatric surgery procedures can be performed laparoscopically, which decreases the complication rate and reduces postoperative pains. Despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. Postoperative risks often concern the nutritional status. It has been shown that, beside different micronutrient deficiencies, bariatric surgery also leads to an increased risk of developing protein malnutrition. Discussed reasons for this are the malabsorption of nutrients and the restricted food intake after surgery, which may lead to reduced protein consumption. Postoperative occurrence of vomiting or different food intolerances may support this effect. Accordingly, if an inadequate supply persists, a protein deficit will occur and this, in turn, may lead to an undesirable reduction in muscle mass and plasma protein levels. Based on this background, numerous studies indicate an increased incidence of protein malnutrition after bariatric surgery by detecting a decrease in levels of albumin and prealbumin, a significant reduction in lean body mass, as well as an inadequate protein intake after surgical treatment.

Dietary proteins have shown to play an important role in body weight regulation. There is evidence that a protein-rich diet is supposed to facilitate weight loss, to support successful weight maintenance, to attain satiety and to preserve lean body mass. Therefore, the use of protein supplements after bariatric surgery may minimize the risk for developing protein malnutrition and hence optimize the postoperative care.

The primary aim of this randomized, placebo-controlled, double blind pilot study was to evaluate the influence of postoperative protein supplementation on body weight reduction, body composition and protein status.

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
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 between 18 and 65 years
  • BMI of 35 kg/m2 or more
  • Indication for laparoscopic sleeve gastrectomy or Roux-en Y gastric bypass

排除标准

  • Renal disease
  • Type 2 diabetes

研究组 & 干预措施

Protein group

Experimental

Patient group which takes daily protein supplements after bariatric surgery over 6 months.

Protein product: Resource Instant Protein 88, Nestlé Health Nutrition

干预措施: Resource Instant Protein 88 (Drug)

Control group

Placebo Comparator

Patient group which takes daily isocaloric placebo after bariatric surgery over 6 months and thus can be compared to the protein group.

Placebo product: Resource Maltodextrin, Nestlé Health Nutrition

干预措施: Resource Maltodextrin (Drug)

结局指标

主要结局

Excess weight loss [%]

时间窗: At month 6

次要结局

  • Content of lean body mass in lost weight [%](At month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan C. Bischoff, MD, Professor

Professor Dr. med. Stephan C. Bischoff

University of Hohenheim

研究点 (1)

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