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

April 12, 2017 updated by: Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina

Effect of Prebiotic and Synbiotic Supplementation on Inflammatory Markers, Metabolic Parameters and Nutritional Status After Roux-en-y Gastric Bypass.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88040-900
        • Hospital Universitario Polydoro Ernani de Sao Thiago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prebiotic
6 g/day of prebiotic (fructooligosaccharides) for 15 days.
Dietary supplement: Prebiotic
Fructooligosaccharides
Experimental: Synbiotic
6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days.
Dietary supplement: Synbiotic
Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019
Placebo Comparator: Placebo
6 g/day of placebo (maltodextrin) for 15 days.
Other: Placebo
Maltodextrin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in IL-1 beta concentrations
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated IL-1 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in IL-6 concentrations
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated IL-6 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in TNF-alpha concentrations
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated TNF-alpha plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in nutritional status
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed anthropometric measures: weight and height (baseline, 30 and 45 days after surgery) for the classification of nutritional status according to BMI
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in risk of inflammatory and nutritional complications
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)
Will be calculated the CRP/albumin ratio, as proposed by Correa et al (2002), using the cutoff points proposed by the same author for the classification of high, medium, decreased or no risk.
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)
Change in fasting glucose concentrations
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed the plasma concentrations of fasting glucose in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in fasting insulin concentrations
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed the plasma concentrations of fasting insulin in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in HOMA-IR index
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed the HOMA-IR index in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in glycated hemoglobin
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated glycated hemoglobin in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in lipid profile
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated lipid profile in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in plasma monounsaturated fatty acids
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed the proportion (%) of plasma monounsaturated fatty acids
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in plasma polyunsaturated fatty acids
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed the proportion (%) of plasma polyunsaturated fatty acids
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Change in plasma saturated fatty acids
Time Frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be assessed the proportion (%) of plasma saturated fatty acids
Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Santa Catarina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ricardo Fernandes, Master's, Universidade Federal de Santa Catarina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 96156587

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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