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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Placebo; Dietary Supplement: Prebiotic; Dietary Supplement: Synbiotic

• Registration Number: NCT02158676
• Lead Sponsor: Universidade Federal de Santa Catarina

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-05
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Study Completion: 2015-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	6 g/day of placebo (maltodextrin) for 15 days.
Prebiotic	Prebiotic	6 g/day of prebiotic (fructooligosaccharides) for 15 days.
Synbiotic	Synbiotic	6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days.

Primary Outcome Measures

Name	Time	Method
Change in IL-1 beta concentrations	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).
Change in IL-6 concentrations	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).
Change in TNF-alpha concentrations	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).

Secondary Outcome Measures

Name	Time	Method
Change in nutritional status	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
Change in risk of inflammatory and nutritional complications	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.
Change in fasting glucose concentrations	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).
Change in fasting insulin concentrations	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).
Change in HOMA-IR index	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).
Change in glycated hemoglobin	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).
Change in lipid profile	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).
Change in plasma monounsaturated fatty acids	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
Change in plasma polyunsaturated fatty acids	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
Change in plasma saturated fatty acids	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

Trial Locations

Locations (1)

Hospital Universitário Polydoro Ernani de São Thiago; 🇧🇷 Florianópolis, Santa Catarina, Brazil