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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03517345
Enrollment
32
Registered
2018-05-07
Start date
2013-04-22
Completion date
2015-02-10
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Bariatric surgery, Prebiotics, gut microbiota, GLP-1, PYY

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

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.

Interventions

DIETARY_SUPPLEMENTPrebiotic

Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d)

DIETARY_SUPPLEMENTControl

The only yogurt consumed as 200 g/d without prebiotic.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma GLP-1 levels changes6 monthsChange in baseline GLP-1 levels (pM) at 6th month. Measured by plasma samples.
Plasma PYY levels changes6 monthsChange in baseline PYY levels (pg/ml) at 6th month. Measured by plasma samples.

Secondary

MeasureTime frameDescription
Appetite regulation6 monthsChange in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales

Other

MeasureTime frameDescription
excess weight loss changes6 monthsChange in excess weight loss (%) throughout 6months.
weight changes6 monthsChange in baseline weight (kg) measurements at 6th month.
serum insulin changes6 monthsChange in serum insulin levels (µU/mL) throughout 6months.
serum glucose changes6 monthsChange in serum glucose levels (mg/dl) throughout 6months.
fat mass changes6 monthsChange in baseline fat mass (kg) measurements at 6th month.
fat free mass changes6 monthsChange in baseline fat free mass (kg) measurements at 6th month.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026