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

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ClinicalTrials.gov Identifier: NCT02505854
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Louise Crovesy de Oliveira, Universidade Federal do Rio de Janeiro

Brief Summary:
The purpose of this study is to evaluate whether contribute with weight loss and improvement of blood sugar and lipemia in obese women.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Probiotic Dietary Supplement: Symbiotic Dietary Supplement: Placebo Not Applicable

Detailed Description:
We will evaluate the effects of probiotic on anthropometric, laboratory, metabolomic, body and gut microbiota composition variables.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Probiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
Dietary Supplement: Probiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
Other Name: Bifidobacterium lactis

Placebo Comparator: Symbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
Dietary Supplement: Symbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
Other Name: Bifidobacterium lactis and fructooligosaccharide

Placebo Comparator: Placebo
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Dietary Supplement: Placebo
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Other Name: Gelatin




Primary Outcome Measures :
  1. Evaluate the effects of probiotic and symbiotic on weight loss of women obese in baseline and after 60 days. [ Time Frame: Baseline and 60 days ]
    Determine and evaluate change in this parameters after intervention.


Secondary Outcome Measures :
  1. Effect of probiotic and symbiotic on blood glucose [ Time Frame: Baseline, 60 days and 15 days after intervention conclusion ]
    Determine and comparing the blood glucose before and after intevention

  2. Effect probiotic and symbiotic on insulin resistance by HOMA-IR calculation [ Time Frame: Baseline and 60 days ]
    Compare insulin resitance before and after intervention and evaluate whether the intervention improvement in this parameter.

  3. Effect probiotic and symbiotic on insulin sensitivity by QUICKY calculation [ Time Frame: Baseline and 60 days ]
    Compare insulin sensibility before and after intervention and evaluate whether the intervention improvement in this parameter.

  4. Effect of probiotic and symbiotic on lipemia [ Time Frame: Baseline and 60 days ]
    Compare lipemia before and after intervention and evaluate whether the intervention improvement in this parameter.

  5. Effect probiotic and symbiotic on blood pressure [ Time Frame: Baseline,60 days and 15 days after intervention conclusion ]
    Determine blood pressure before and 60 days of intervention and 15 days after intervention conclusion.

  6. Effect of probiotic and symbiotic on compoused gut microbiota [ Time Frame: Baseline, 60 days and 15 days after intervention conclusion ]
    Determine and comparing the amount filos and Bifidobacterium lactist in gut microbiota

  7. 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.

  8. Effect of probiotic and symbiotic on gastrointestinal symptons [ Time Frame: Baseline,60 days and 15 days after intervention conclusion ]
    Determine gastrintestinais symptons related to the consumption of intervention.



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505854


Locations
Brazil
Louise Crovesy de Oliveira
Rio de Janeiro, Brazil, 21
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: Louise C Oliveira, MD student Universidade Federal do Rio de Janeiro

Additional Information:
Responsible Party: Louise Crovesy de Oliveira, Master's degree, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02505854     History of Changes
Other Study ID Numbers: CEP 104-14
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Louise Crovesy de Oliveira, Universidade Federal do Rio de Janeiro:
Obesity
Probiotic
Symbiotic
Weight loss
Gut microbiota
Bifidobacterium lactis
Fructooligosaccharide
Blood sugar
Lipemia

Additional relevant MeSH terms:
Body Weight
Hyperlipidemias
Signs and Symptoms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases