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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02958644
Acronym
Synbiotic
Enrollment
180
Registered
2016-11-08
Start date
2017-09-30
Completion date
2018-07-31
Last updated
2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Class III

Keywords

synbiotic, obesity, body mass index, microbiota

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).

Interventions

DIETARY_SUPPLEMENTSynbiotics

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Hospital Dona Helena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Body mass index90 days

Secondary

MeasureTime frameDescription
Total cholesterol90 days
Plasma LDL-cholesterol90 days
Plasma HDL-cholesterol90 days
Plasma triglycerides90 days
Blood glucose90 daysFasting blood glucose
Glycated hemoglobin90 days
Plasma C-reactive protein90 days
Arterial blood pressure90 daysSystolic and diastolic arterial blood pressure
Interleucin I-ß90 days
Interleucin 690 days
Albumin90 days
Tumoral Necrose Factor (TNF-α)90 days
Adverse events90 days
Plasma insulin90 days

Countries

Brazil

Contacts

Primary ContactMarilyn G Ferreira, PhD
marilyn.ferreira@ielusc.br+55 47 91029228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026