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

Obesity Class III Clinical Trial

— Synbiotic  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02958644
• Other study ID #: HDonaHelena
• Status: Not yet recruiting
• Phase: N/A
• First received: November 4, 2016
• Last updated: September 15, 2017
• Start date: September 2017
• Est. completion date: July 2018

Study information

• Verified date: September 2017
• Source: Hospital Dona Helena
• Contact: Marilyn G Ferreira, PhD
• Phone: +55 47 91029228
• Email: marilyn.ferreira[@]ielusc.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity Class III
• Obesity, Morbid

Intervention

Dietary Supplement:
• Synbiotics
12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
• Placebo
12g / day placebo (polydextrose) supplemented orally for 90 days

Locations

Country	Name	City	State
Brazil	Hospital Dona Helena	Joinville	Santa Catarina
Brazil	Hospital Regional Hans Dieter Schmidt	Joinville	SC
Brazil	Hospital do Coração	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Dona Helena

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index		90 days
Secondary	Plasma C-reactive protein		90 days
Secondary	Total cholesterol		90 days
Secondary	Plasma LDL-cholesterol		90 days
Secondary	Plasma HDL-cholesterol		90 days
Secondary	Plasma triglycerides		90 days
Secondary	Blood glucose	Fasting blood glucose	90 days
Secondary	Glycated hemoglobin		90 days
Secondary	Plasma insulin		90 days
Secondary	Arterial blood pressure	Systolic and diastolic arterial blood pressure	90 days
Secondary	Interleucin I-ß		90 days
Secondary	Interleucin 6		90 days
Secondary	Albumin		90 days
Secondary	Tumoral Necrose Factor (TNF-a)		90 days
Secondary	Adverse events		90 days