Obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. Potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. Probiotics are living bacteria which are found in the normal gut microbiota. Synbiotics are combinations of both prebiotics and probiotics. Their use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including severe obesity. This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass index in participants with obesity class III, with follow up of 90 days.
Obesity has been discussed as one of the major diseases that require scientific and technological innovations for its control is obesity and studies indicate that microbiota of obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function and the combination of toxins to protein. Potential mediators of intestinal microbiota are prebiotics, probiotics and synbiotics, supplements considered safe because they are naturally contained in food and human microbiota. Its use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including in severe obesity. This study aims to analyze the effect of synbiotics supplementation on body mass index in participants diagnosed with morbid obesity. The methodology used is the randomized clinical trial, placebo-controlled with blinding of patients, healthcare staff and outcome assessors, with follow-up of 90 days. Patients will be randomized into two groups: control group to receive placebo (polydextrose - 12 g / day) and synbiotic group - group supplemented with synbiotic (fructo-oligosaccharide and probiotics - 12 g / day). Probiotics are: Lactobacillus acidophilus; Lactobacillus rhamnosus; Lactobacillus paracasei; Bifïdobacterium lactis. At the moments proposed in this study, will be conducted assessments of food intake, nutritional status and metabolic / inflammatory parameters (body mass index, high-sensitivity C-reactive protein, albumin, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol, fasting blood glucose, glycated hemoglobin, fasting insulin, weight, height).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
12g / day placebo (polydextrose) supplemented orally for 90 days
Hospital Dona Helena
Joinville, Santa Catarina, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Hospital do Coração
São Paulo, São Paulo, Brazil
Body mass index
Time frame: 90 days
Plasma C-reactive protein
Time frame: 90 days
Total cholesterol
Time frame: 90 days
Plasma LDL-cholesterol
Time frame: 90 days
Plasma HDL-cholesterol
Time frame: 90 days
Plasma triglycerides
Time frame: 90 days
Blood glucose
Fasting blood glucose
Time frame: 90 days
Glycated hemoglobin
Time frame: 90 days
Plasma insulin
Time frame: 90 days
Arterial blood pressure
Systolic and diastolic arterial blood pressure
Time frame: 90 days
Interleucin I-ß
Time frame: 90 days
Interleucin 6
Time frame: 90 days
Albumin
Time frame: 90 days
Tumoral Necrose Factor (TNF-α)
Time frame: 90 days
Adverse events
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.