Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-07-31

Brief Summary

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The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.

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Detailed Description

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The study will recruit patients submitted to roux-en-y gastric bypass. Individuals that meet the inclusion criteria will be randomized by means of a computer program on three study groups: 1) Prebiotic group: Oral supplementation with 6g/day of prebiotic for 15 days. 2) Synbiotic group: Oral supplementation with 6g/day of synbiotic for 15 days. 3) Placebo group (control): Oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. Will be assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid profile, glycemic status and insulin resistance) and nutritional status. Blood samples will be collected before the surgery and the supplementation will begin 30 days after surgery.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Prebiotic

6 g/day of prebiotic (fructooligosaccharides) for 15 days.

Group Type EXPERIMENTAL

Prebiotic

Intervention Type DIETARY_SUPPLEMENT

Fructooligosaccharides

Synbiotic

6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days.

Group Type EXPERIMENTAL

Synbiotic

Intervention Type DIETARY_SUPPLEMENT

Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019

Placebo

6 g/day of placebo (maltodextrin) for 15 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Maltodextrin

Interventions

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Prebiotic

Fructooligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Synbiotic

Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age greater than 18 years and less than 65 years
* Body mass index (BMI)\> 40kg/m2 or\> 35kg/m2 with at least one comorbidity
* Failure in the non-pharmacological and pharmacological treatment.

Exclusion Criteria

* Significant intellectual limitations without adequate family support.
* Uncontrolled psychiatric disorder.
* Alcohol dependence and / or illicit drugs dependence.
* Current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants
* Display intolerance prebiotics and / or probiotics and / or symbiotic
* Having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No