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

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517345
• Other study ID #: 31806
• Status: Completed
• Phase: N/A
• Start date: April 22, 2013
• Est. completion date: February 10, 2015

Study information

• Verified date: April 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 10, 2015
• Est. primary completion date: December 5, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Dietary Supplement:
• Prebiotic
Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d)
• Control
The only yogurt consumed as 200 g/d without prebiotic.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight changes	Change in baseline weight (kg) measurements at 6th month.	6 months
Other	fat mass changes	Change in baseline fat mass (kg) measurements at 6th month.	6 months
Other	fat free mass changes	Change in baseline fat free mass (kg) measurements at 6th month.	6 months
Other	excess weight loss changes	Change in excess weight loss (%) throughout 6months.	6 months
Other	serum glucose changes	Change in serum glucose levels (mg/dl) throughout 6months.	6 months
Other	serum insulin changes	Change in serum insulin levels (µU/mL) throughout 6months.	6 months
Primary	Plasma GLP-1 levels changes	Change in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.	6 months
Primary	Plasma PYY levels changes	Change in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.	6 months
Secondary	Appetite regulation	Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales	6 months