Obesity Class III Clinical Trial
Official title:
Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
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).
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