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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Obesity Class III

Intervention / Treatment
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* Dietary Supplement: Synbiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synbiotics<br>Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days. | Dietary Supplement: Synbiotics<br>* 12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days<br>* Other names: Fructo-oligosaccharide and probiotics;|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo<br>* 12g / day placebo (polydextrose) supplemented orally for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | 90 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synbiotic, obesity, body mass index, microbiota