Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
NCT ID: NCT02958644
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2017-09-30
2018-07-31
Brief Summary
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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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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Synbiotics
Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days.
Synbiotics
12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
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.
Placebo
12g / day placebo (polydextrose) supplemented orally for 90 days
Interventions
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Synbiotics
12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
Placebo
12g / day placebo (polydextrose) supplemented orally for 90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Intolerance to prebiotics and probiotics
18 Years
ALL
No
Sponsors
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Hospital Dona Helena
OTHER
Responsible Party
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Marilyn Gonçalves Ferreira Kuntz
Principal Investigator
Principal Investigators
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Marilyn G Ferreira, PhD
Role: STUDY_CHAIR
Hospital Dona Helena
Locations
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Hospital Dona Helena
Joinville, Santa Catarina, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Hospital do Coração
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HDonaHelena
Identifier Type: -
Identifier Source: org_study_id