Obesity
Conditions
Keywords
Roux-en-y gastric bypass, Inflammatory markers, Nutritional status, Fatty acids, Glucose, Prebiotic, Synbiotic
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic
Fructooligosaccharides
DIETARY_SUPPLEMENTSynbiotic
Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019
OTHERPlacebo
Maltodextrin
Sponsors
Universidade Federal de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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). |
Countries
Brazil
Outcome results
None listed