Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03517345
Recruitment Status : Completed
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Information provided by (Responsible Party):
Fulya Turker, Istanbul University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bariatric Surgery Dietary Supplement: Prebiotic Dietary Supplement: Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigating the Effects of Prebiotic Supplementation on Metabolic Effects of Roux-en-Y Gastric Bypass Surgery: A Prospective Randomized Trial
Actual Study Start Date : April 22, 2013
Actual Primary Completion Date : December 5, 2014
Actual Study Completion Date : February 10, 2015

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.

Primary Outcome Measures :
  1. Plasma GLP-1 levels changes [ Time Frame: 6 months ]
    Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.

  2. Plasma PYY levels changes [ Time Frame: 6 months ]
    Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.

Secondary Outcome Measures :
  1. Appetite regulation [ Time Frame: 6 months ]
    Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales

Other Outcome Measures:
  1. weight changes [ Time Frame: 6 months ]
    Change in baseline weight (kg) measurements at 6th month.

  2. fat mass changes [ Time Frame: 6 months ]
    Change in baseline fat mass (kg) measurements at 6th month.

  3. fat free mass changes [ Time Frame: 6 months ]
    Change in baseline fat free mass (kg) measurements at 6th month.

  4. excess weight loss changes [ Time Frame: 6 months ]
    Change in excess weight loss (%) throughout 6months.

  5. serum glucose changes [ Time Frame: 6 months ]
    Change in serum glucose levels (mg/dl) throughout 6months.

  6. serum insulin changes [ Time Frame: 6 months ]
    Change in serum insulin levels (µU/mL) throughout 6months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Layout table for additonal information
Responsible Party: Fulya Turker, Principle Investigator, Istanbul University Identifier: NCT03517345     History of Changes
Other Study ID Numbers: 31806
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fulya Turker, Istanbul University:
Bariatric surgery
gut microbiota