Clinical trial NCT02958644: Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
Official title: Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity Class III
Keywords: synbiotic
obesity
body mass index
microbiota
Lead sponsor: Hospital Dona Helena
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Body mass index
timeFrame: 90 days
Secondary outcomes:
measure: Plasma C-reactive protein
timeFrame: 90 days
measure: Total cholesterol
timeFrame: 90 days
measure: Plasma LDL-cholesterol
timeFrame: 90 days
measure: Plasma HDL-cholesterol
timeFrame: 90 days
measure: Plasma triglycerides
timeFrame: 90 days
measure: Blood glucose
timeFrame: 90 days
measure: Glycated hemoglobin
timeFrame: 90 days
measure: Plasma insulin
timeFrame: 90 days
measure: Arterial blood pressure
timeFrame: 90 days
measure: Interleucin I-ß
timeFrame: 90 days
measure: Interleucin 6
timeFrame: 90 days
measure: Albumin
timeFrame: 90 days
measure: Tumoral Necrose Factor (TNF-α)
timeFrame: 90 days
measure: Adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Joinville
country: Brazil
facility: Hospital Dona Helena
state: Santa Catarina
city: Joinville
country: Brazil
facility: Hospital Regional Hans Dieter Schmidt
state: SC
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
Study officials:
affiliation: Hospital Dona Helena
name: Marilyn G Ferreira, PhD
role: STUDY_CHAIR
References: