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AzTrials

ObesityNCT02158676

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

A study testing Prebiotic and Synbiotic in people with Obesity, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity
What is being tested?
Prebiotic and Synbiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteBrazil
Study dates
Oct 2013to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Universitário Polydoro Ernani de São Thiago

    Florianópolis, Santa Catarina, 88040-900

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
Prebiotic, Synbiotic, Placebo
Keywords
Roux-en-y gastric bypass, Inflammatory markers, Nutritional status, Fatty acids, Glucose, Prebiotic, Synbiotic
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrebioticDietary supplement

    Fructooligosaccharides

  • SynbioticDietary supplement

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

  • PlaceboOther

    Maltodextrin

Study groups in NCT02158676
Study groupRoleWhat they receive
PrebioticExperimental6 g/day of prebiotic (fructooligosaccharides) for 15 days.
Receives: Dietary Supplement: Prebiotic
SynbioticExperimental6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days.
Receives: Dietary Supplement: Synbiotic
PlaceboPlacebo comparator6 g/day of placebo (maltodextrin) for 15 days.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in IL-1 beta concentrations

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  2. Change in IL-6 concentrations

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  3. Change in TNF-alpha concentrations

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

Secondary outcomes (10)

  1. Change in nutritional status

    Will be assessed anthropometric measures: weight and height (baseline, 30 and 45 days after surgery) for the classification of nutritional status according to BMI

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  2. Change in risk of inflammatory and nutritional complications

    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.

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)

  3. Change in fasting glucose concentrations

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  4. Change in fasting insulin concentrations

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  5. Change in HOMA-IR index

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  6. Change in glycated hemoglobin

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  7. Change in lipid profile

    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).

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  8. Change in plasma monounsaturated fatty acids

    Will be assessed the proportion (%) of plasma monounsaturated fatty acids

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  9. Change in plasma polyunsaturated fatty acids

    Will be assessed the proportion (%) of plasma polyunsaturated fatty acids

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

  10. Change in plasma saturated fatty acids

    Will be assessed the proportion (%) of plasma saturated fatty acids

    Measured: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionMay 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158676
Sponsor's protocol ID
96156587
Status last verified
Apr 2017
First submitted
2 Jun 2014
Last updated
14 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Fernandes R, Beserra BT, Mocellin MC, Kuntz MG, da Rosa JS, de Miranda RC, Schreiber CS, Frode TS, Nunes EA, Trindade EB. Effects of Prebiotic and Synbiotic Supplementation on Inflammatory Markers and Anthropometric Indices After Roux-en-Y Gastric Bypass: A Randomized, Triple-blind, Placebo-controlled Pilot Study. J Clin Gastroenterol. 2016 Mar;50(3):208-17. doi: 10.1097/MCG.0000000000000328.

    PubMed 25909598

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic and Synbiotic in people with Obesity, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in IL-1 beta concentrations (time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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