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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Hospital Universitário Polydoro Ernani de São Thiago
Florianópolis, Santa Catarina, Brazil
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
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
Time frame: 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.
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).