Clinical trial NCT02158676: Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.
Official title: Effect of Prebiotic and Synbiotic Supplementation on Inflammatory Markers, Metabolic Parameters and Nutritional Status After Roux-en-y Gastric Bypass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Roux-en-y gastric bypass
Inflammatory markers
Nutritional status
Fatty acids
Glucose
Prebiotic
Synbiotic
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in IL-1 beta concentrations
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in IL-6 concentrations
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in TNF-alpha concentrations
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary outcomes:
measure: Change in nutritional status
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in risk of inflammatory and nutritional complications
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)
measure: Change in fasting glucose concentrations
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in fasting insulin concentrations
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in HOMA-IR index
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in glycated hemoglobin
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in lipid profile
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in plasma monounsaturated fatty acids
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in plasma polyunsaturated fatty acids
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
measure: Change in plasma saturated fatty acids
timeFrame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Hospital Universitário Polydoro Ernani de São Thiago
state: Santa Catarina
Study officials:
affiliation: Universidade Federal de Santa Catarina
name: Ricardo Fernandes, Master's
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.