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临床试验/NCT03517345
NCT03517345已完成不适用

Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial

Istanbul University0 个研究点目标入组 32 人开始时间: 2013年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Plasma GLP-1 levels changes

研究概览

简要总结

In this study, it is aimed to evaluate whether the addition of prebiotics to patients' post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the participants were randomized prebiotic with conventional yogurt, while the other half were randomized only conventional yogurt as a snack

详细描述

Following bariatric surgery, positive alterations are observed in gut microbiota, intestinal peptides, and inflammatory cytokines. Previous studies demonstrate that prebiotic use alone in a tolerable dose (which is 10 g/day) among obese, overweight, or diabetic individuals accelerated the weight loss by reducing hunger and food intake. Furthermore, it could also contribute to the improvement of glucose homeostasis by increase postprandial PYY and GLP-1 levels. Prebiotics feeds healthy intestinal bacteria and enhances their positive effects. The present positive effects appear with SCFAs that stimulates PYY and GLP-1 release and produced by fermentation of prebiotics by bacteria. From this point forth, it was hypothesized that post-operative pre-probiotic usage may enhance the effects of Roux-en-Y Gastric Bypass (RYGB). In addition, administration of pre-probiotics following RYGB may be considered as a simple and cheap treatment support, especially for protecting patients with poor medicine compliance against nutritional deficiencies, as well as for diabetic patients whose glucose regulations deteriorate in the long term, and for those who regain weight.

With the result that the effects of prebiotic supplementation on metabolic results of RYGB surgery in this prospective, randomized, controlled study with a duration of 24 weeks were tested.

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

入选标准

  • BMI >40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)

排除标准

  • Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.

研究组 & 干预措施

Prebiotic group

Experimental

Given a prebiotic product (inulin + oligofructose; 5 g) mixed with conventional yogurt (100 g) which given as snack, twice a day.

干预措施: Prebiotic (Dietary Supplement)

Control group

Experimental

Given conventional yogurt (100 g) which given as snack, twice a day.

干预措施: Control (Dietary Supplement)

结局指标

主要结局

Plasma GLP-1 levels changes

时间窗: 6 months

Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.

Plasma PYY levels changes

时间窗: 6 months

Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.

次要结局

  • Appetite regulation(6 months)

研究者

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

Fulya Turker

Principle Investigator

Istanbul University

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