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

Not Applicable

• Conditions: Obesity Class III
• Interventions: Dietary Supplement: Synbiotics; Dietary Supplement: Placebo

• Registration Number: NCT02958644
• Lead Sponsor: Hospital Dona Helena

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-08
• Status Verified: 2017-09
• Study Start: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-19
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Body mass index	90 days

Secondary Outcome Measures

Name	Time	Method
Adverse events	90 days
Total cholesterol	90 days
Plasma HDL-cholesterol	90 days
Plasma triglycerides	90 days
Tumoral Necrose Factor (TNF-α)	90 days
Plasma C-reactive protein	90 days
Plasma LDL-cholesterol	90 days
Glycated hemoglobin	90 days
Arterial blood pressure	90 days	Systolic and diastolic arterial blood pressure
Interleucin I-ß	90 days
Interleucin 6	90 days
Albumin	90 days
Blood glucose	90 days	Fasting blood glucose
Plasma insulin	90 days

Trial Locations

Locations (3)

Hospital Dona Helena; 🇧🇷 Joinville, Santa Catarina, Brazil

Hospital Regional Hans Dieter Schmidt; 🇧🇷 Joinville, SC, Brazil

Hospital do Coração; 🇧🇷 São Paulo, SP, Brazil