- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02958644
Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity (Synbiotic)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marilyn G Ferreira, PhD
- Phone Number: +55 47 91029228
- Email: marilyn.ferreira@ielusc.br
Study Locations
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SC
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Joinville, SC, Brazil
- Hospital Regional Hans Dieter Schmidt
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Contact:
- Marilyn G Ferreira, PhD
- Phone Number: +55 47 91029228
- Email: marilyn.ferreira@ielusc.br
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SP
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São Paulo, SP, Brazil, 04004-030
- Hospital do Coracao
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Contact:
- Bernardete Weber, PhD
- Email: bweber@hcor.com.br
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Santa Catarina
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Joinville, Santa Catarina, Brazil, 89204-250
- Hospital Dona Helena
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Contact:
- Micheli Arruda, R.N.
- Phone Number: +554734365500
- Email: micheli.c@donahelena.com.br
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Synbiotics
Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days.
|
12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
Other Names:
|
Placebo Comparator: 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. |
12g / day placebo (polydextrose) supplemented orally for 90 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body mass index
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Albumin
Time Frame: 90 days
|
90 days
|
|
Adverse events
Time Frame: 90 days
|
90 days
|
|
Plasma C-reactive protein
Time Frame: 90 days
|
90 days
|
|
Total cholesterol
Time Frame: 90 days
|
90 days
|
|
Plasma LDL-cholesterol
Time Frame: 90 days
|
90 days
|
|
Plasma HDL-cholesterol
Time Frame: 90 days
|
90 days
|
|
Plasma triglycerides
Time Frame: 90 days
|
90 days
|
|
Blood glucose
Time Frame: 90 days
|
Fasting blood glucose
|
90 days
|
Glycated hemoglobin
Time Frame: 90 days
|
90 days
|
|
Plasma insulin
Time Frame: 90 days
|
90 days
|
|
Arterial blood pressure
Time Frame: 90 days
|
Systolic and diastolic arterial blood pressure
|
90 days
|
Interleucin I-ß
Time Frame: 90 days
|
90 days
|
|
Interleucin 6
Time Frame: 90 days
|
90 days
|
|
Tumoral Necrose Factor (TNF-α)
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marilyn G Ferreira, PhD, Hospital Dona Helena
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HDonaHelena
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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