Trial | NCT02958644  Report issue

Official Title

Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    180
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 Started
Sep 30
2017
Anticipated
Primary Completion
Dec 31
2017
Anticipated
Study Completion
Jul 31
2018
Anticipated
Last Update
Sep 19
2017

Dietary Supplement Synbiotics

12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days

  • Other names: Fructo-oligosaccharide and probiotics

Dietary Supplement Placebo

12g / day placebo (polydextrose) supplemented orally for 90 days

Synbiotics Experimental

Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days.

Placebo Placebo Comparator

Placebo - polydextrose 12g /day supplemented orally for 90 days. The study supplements are packed in identical envelopes containing either 12g of oral powder fructo-oligosaccharide and probiotics or placebo to be diluted in water. The powder and the solution were identical in appearance, taste, and smell.

Criteria 

Inclusion Criteria:

Obesity class III (body mass index ≥40kg/m2)

Exclusion Criteria:

Current use of prebiotics and probiotics or use in the last three months
Intolerance to prebiotics and probiotics
No Results Posted