Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
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
- 否
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
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
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
Fulya Turker
Principle Investigator
Istanbul University
