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

Study Overview
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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.

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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Prebiotic
* Dietary Supplement: Synbiotic
* Other: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic<br>6 g/day of prebiotic (fructooligosaccharides) for 15 days. | Dietary Supplement: Prebiotic<br>* Fructooligosaccharides<br>|
| Experimental: Synbiotic<br>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<br>* Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019<br>|
| Placebo Comparator: Placebo<br>6 g/day of placebo (maltodextrin) for 15 days. | Other: Placebo<br>* Maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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. | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation) | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| 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). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). | 
| Change in plasma monounsaturated fatty acids | 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 | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-en-y gastric bypass, Inflammatory markers, Nutritional status, Fatty acids, Glucose, Prebiotic, Synbiotic