Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women

December 5, 2019 updated by: Louise Crovesy de Oliveira, Universidade Federal do Rio de Janeiro
The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid profile, metabolomic profile, and gut microbiota composition variables in women with obesity.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21
        • Louise Crovesy de Oliveira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women;
  • Adult;
  • Obese (BMI between 30 and 39,9 Kg/m²).

Exclusion Criteria:

  • Pregnancy or nursing;
  • Smokers;
  • Drinkers;
  • Use of drug or phytotherapic;
  • Diagnosis of any cronic disease;
  • Daily consumption of yogurt.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin
Dietary supplement: Probiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
Other Names:
  • Bifidobacterium lactis
Active Comparator: Symbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide
Dietary supplement: Symbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
Other Names:
  • Bifidobacterium lactis and fructooligosaccharide
Placebo Comparator: Placebo
Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin
Dietary supplement: Placebo
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Other Names:
  • Gelatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of probiotic and symbiotic on weight loss of women obese
Time Frame: Baseline and 60 days and 15 days after the end of the intervention
Determine and evaluate change in body weight and body mass index after intervention.
Baseline and 60 days and 15 days after the end of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of probiotic and symbiotic on blood glucose
Time Frame: Baseline, 60 days and 15 days after the end of the intervention
Determine and comparing the blood glucose in plasma before and after intervention
Baseline, 60 days and 15 days after the end of the intervention
Effect of probiotic and symbiotic on insulin resistance
Time Frame: Baseline and 60 days
Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter.
Baseline and 60 days
Effect of probiotic and symbiotic on lipid profile
Time Frame: Baseline and 60 days
Compare lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, triglyceride) in serum of blood before and after intervention and evaluate whether the intervention improvement in this parameter.
Baseline and 60 days
Effect probiotic and symbiotic on blood pressure
Time Frame: Baseline,60 days and 15 days after intervention conclusion
Determine blood pressure and evaluate whether the intervention improvement blood pressure.
Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on gut microbiota composition
Time Frame: Baseline, 60 days and 15 days after intervention conclusion
Determine and comparing the amount filos (Fimicutes, Bacteroidetes, Actinobacteria, Verrucomicrobia e Proteobacteria) in gut microbiota and whether the change in microbiota composition continue after stop probiotic and symbiotic intake
Baseline, 60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on stool consitency by Bristol scale
Time Frame: Baseline,60 days and 15 days after intervention conclusion
Determine and comparing the stool consistency by Bristol scale. The Bristol scale is composed of 7 different stool consistency, being 1 and 2 lumpy, 3 and 4 normal, 5 to 7 loose.
Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on gastrointestinal symptons
Time Frame: Baseline,60 days and 15 days after intervention conclusion
Evaluate the presence of gastrointestinal symptoms related to the probiotic and symbiotic. The gastrointestinal symptoms analyzed were abdominal pains, abdominal distension and abdominal discomfort, flatus, borborygmus using the Likert scale of 5 point, which 0 is absence of symptom and 4 is every day.
Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on metabolomic profile
Time Frame: Baseline and 60 days
Determine and comparing change in metabolomic profile before and after intervention. The metabolomic profile was evaluated in the serum of blood Bruker DRX 500 MHz equipment (Bruker Spectrospin, Karlsruhe, Germany) generating hydrogen isotope 1 (1H)-NMR spectra, that was compared to database Human Metabolome Data Base.
Baseline and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Louise C Oliveira, MD student, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 104-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Obesity

Clinical Trials on Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe