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

NCT02958644 | Unknown

• 1 other identifier: HDonaHelena
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity Class III

Keywords

synbiotic; obesity; body mass index; microbiota

Outcome Measures

Primary Outcomes (1)

• Body mass index

  90 days

Secondary Outcomes (14)

• Plasma C-reactive protein

  90 days

• Total cholesterol

  90 days

• Plasma LDL-cholesterol

  90 days

• Plasma HDL-cholesterol

  90 days

• Plasma triglycerides

  90 days

Study Arms (2)

Synbiotics

EXPERIMENTAL

Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days.

Dietary Supplement: Synbiotics

Placebo

PLACEBO COMPARATOR

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

Interventions

Synbiotics DIETARY_SUPPLEMENT

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

Also known as: Fructo-oligosaccharide and probiotics

Synbiotics

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obesity class III (body mass index ≥40kg/m2)

You may not qualify if:

• Current use of prebiotics and probiotics or use in the last three months
• Intolerance to prebiotics and probiotics

Sponsors & Collaborators

• Hospital Dona Helena: lead

Study Sites (3)

Hospital Dona Helena

Joinville, Santa Catarina, 89204-250, Brazil

Location

Hospital Regional Hans Dieter Schmidt

Joinville, Santa Catarina, Brazil

Location

Hospital do Coração

São Paulo, São Paulo, 04004-030, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Synbiotics; Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marilyn G Ferreira, PhD

  Hospital Dona Helena

  STUDY CHAIR

Central Study Contacts

Marilyn G Ferreira, PhD

CONTACT

+55 47 91029228; marilyn.ferreira@ielusc.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 8, 2016
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months following article publication.
• 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.

Locations

BR (3)