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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic
Symbiotic
Placebo
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Probiotic, Symbiotic, Weight loss, Gut microbiota, Bifidobacterium lactis, Fructooligosaccharide, Blood sugar, Lipemia, Metabolome

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Louise Crovesy de Oliveira

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Symbiotic

Placebo

Arm Description

Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin

Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide

Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin

Outcomes

Primary Outcome Measures

Evaluate the effect of probiotic and symbiotic on weight loss of women obese
Determine and evaluate change in body weight and body mass index after intervention.

Secondary Outcome Measures

Effect of probiotic and symbiotic on blood glucose
Determine and comparing the blood glucose in plasma before and after intervention
Effect of probiotic and symbiotic on insulin resistance
Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter.
Effect of probiotic and symbiotic on lipid profile
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.
Effect probiotic and symbiotic on blood pressure
Determine blood pressure and evaluate whether the intervention improvement blood pressure.
Effect of probiotic and symbiotic on gut microbiota composition
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
Effect of probiotic and symbiotic on stool consitency by Bristol scale
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.
Effect of probiotic and symbiotic on gastrointestinal symptons
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.
Effect of probiotic and symbiotic on metabolomic profile
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.

Full Information

First Posted
July 16, 2015
Last Updated
December 5, 2019
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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1. Study Identification

Unique Protocol Identification Number
NCT02505854
Brief Title
Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
Official Title
Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Probiotic, Symbiotic, Weight loss, Gut microbiota, Bifidobacterium lactis, Fructooligosaccharide, Blood sugar, Lipemia, Metabolome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin
Arm Title
Symbiotic
Arm Type
Active Comparator
Arm Description
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Bifidobacterium lactis
Intervention Description
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Symbiotic
Other Intervention Name(s)
Bifidobacterium lactis and fructooligosaccharide
Intervention Description
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Gelatin
Intervention Description
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Primary Outcome Measure Information:
Title
Evaluate the effect of probiotic and symbiotic on weight loss of women obese
Description
Determine and evaluate change in body weight and body mass index after intervention.
Time Frame
Baseline and 60 days and 15 days after the end of the intervention
Secondary Outcome Measure Information:
Title
Effect of probiotic and symbiotic on blood glucose
Description
Determine and comparing the blood glucose in plasma before and after intervention
Time Frame
Baseline, 60 days and 15 days after the end of the intervention
Title
Effect of probiotic and symbiotic on insulin resistance
Description
Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter.
Time Frame
Baseline and 60 days
Title
Effect of probiotic and symbiotic on lipid profile
Description
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.
Time Frame
Baseline and 60 days
Title
Effect probiotic and symbiotic on blood pressure
Description
Determine blood pressure and evaluate whether the intervention improvement blood pressure.
Time Frame
Baseline,60 days and 15 days after intervention conclusion
Title
Effect of probiotic and symbiotic on gut microbiota composition
Description
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
Time Frame
Baseline, 60 days and 15 days after intervention conclusion
Title
Effect of probiotic and symbiotic on stool consitency by Bristol scale
Description
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.
Time Frame
Baseline,60 days and 15 days after intervention conclusion
Title
Effect of probiotic and symbiotic on gastrointestinal symptons
Description
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.
Time Frame
Baseline,60 days and 15 days after intervention conclusion
Title
Effect of probiotic and symbiotic on metabolomic profile
Description
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.
Time Frame
Baseline and 60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise C Oliveira, MD student
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louise Crovesy de Oliveira
City
Rio de Janeiro
ZIP/Postal Code
21
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33565558
Citation
Crovesy L, El-Bacha T, Rosado EL. Modulation of the gut microbiota by probiotics and symbiotics is associated with changes in serum metabolite profile related to a decrease in inflammation and overall benefits to metabolic health: a double-blind randomized controlled clinical trial in women with obesity. Food Funct. 2021 Mar 15;12(5):2161-2170. doi: 10.1039/d0fo02748k.
Results Reference
derived

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

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