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: Unknown
• Conditions: Obesity Class III
• Intervention / Treatment: Dietary supplement: Synbiotics; Dietary supplement: Placebo

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: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SC
    • Joinville, SC, Brazil
      • Hospital Regional Hans Dieter Schmidt
  • SP
    • São Paulo, SP, Brazil, 04004-030
      • Hospital do Coracao
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89204-250
      • Hospital Dona Helena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synbiotics; Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days.	Dietary supplement: Synbiotics; 12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days; Other Names: Fructo-oligosaccharide and probiotics
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.	Dietary supplement: Placebo; 12g / day placebo (polydextrose) supplemented orally for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body mass index	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin		90 days
Adverse events		90 days
Plasma C-reactive protein		90 days
Total cholesterol		90 days
Plasma LDL-cholesterol		90 days
Plasma HDL-cholesterol		90 days
Plasma triglycerides		90 days
Blood glucose	Fasting blood glucose	90 days
Glycated hemoglobin		90 days
Plasma insulin		90 days
Arterial blood pressure	Systolic and diastolic arterial blood pressure	90 days
Interleucin I-ß		90 days
Interleucin 6		90 days
Tumoral Necrose Factor (TNF-α)		90 days

Collaborators and Investigators

• Sponsor: Hospital Dona Helena
• Investigators: Study Chair: Marilyn G Ferreira, PhD, Hospital Dona Helena

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: body mass index; obesity; synbiotic; microbiota
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: HDonaHelena

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the database containing de-identified individual participant data, data dictionary documentation, statistical analysis plan, and analysis code. Beginning 6 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals.
• IPD Sharing Time Frame: Beginning 6 months following article publication.
• IPD Sharing Access Criteria: The trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No