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Completed

NCT Number: NCT03517345

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotic

Dietary Supplement

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

Control

Dietary Supplement

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

Primary outcomes

  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 outcomes

  1. Appetite regulation

    Time frame: 6 months

    Change in baseline appetite at 6th month. Subjective appetite assessed with visual analog scales

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 7, 2018
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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