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

NCT02958644 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-09-19

No results posted yet for this study

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.

Conditions

  • Obesity Class III

Interventions

DIETARY_SUPPLEMENT

Synbiotics

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Hospital Dona Helena

    lead OTHER

Principal Investigators

  • Marilyn G Ferreira, PhD · Hospital Dona Helena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2017-12-31
Completion
2018-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958644 on ClinicalTrials.gov