The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Dietary Supplement: Prebiotic
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band) Exclusion Criteria: I Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic group<br>Given a prebiotic product (inulin + oligofructose; 5 g) mixed with conventional yogurt (100 g) which given as snack, twice a day. | Dietary Supplement: Prebiotic<br>* Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d)<br>|
| Experimental: Control group<br>Given conventional yogurt (100 g) which given as snack, twice a day. | Dietary Supplement: Control<br>* The only yogurt consumed as 200 g/d without prebiotic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GLP-1 levels changes | Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples. | 6 months | 
| Plasma PYY levels changes | Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite regulation | Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, gut microbiota, GLP-1, PYY, Prebiotics