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

April 24, 2018 updated by: Fulya Turker, Istanbul University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma GLP-1 levels changes
Time Frame: 6 months
Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.
6 months
Plasma PYY levels changes
Time Frame: 6 months
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
Time Frame: 6 months
Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight changes
Time Frame: 6 months
Change in baseline weight (kg) measurements at 6th month.
6 months
fat mass changes
Time Frame: 6 months
Change in baseline fat mass (kg) measurements at 6th month.
6 months
fat free mass changes
Time Frame: 6 months
Change in baseline fat free mass (kg) measurements at 6th month.
6 months
excess weight loss changes
Time Frame: 6 months
Change in excess weight loss (%) throughout 6months.
6 months
serum glucose changes
Time Frame: 6 months
Change in serum glucose levels (mg/dl) throughout 6months.
6 months
serum insulin changes
Time Frame: 6 months
Change in serum insulin levels (µU/mL) throughout 6months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2013

Primary Completion (Actual)

December 5, 2014

Study Completion (Actual)

February 10, 2015

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 31806

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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