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

NCT ID: NCT02505854

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Obesity Probiotic Symbiotic Weight loss Gut microbiota Bifidobacterium lactis Fructooligosaccharide Blood sugar Lipemia Metabolome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic

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

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Symbiotic

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

Group Type ACTIVE_COMPARATOR

Symbiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Symbiotic

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bifidobacterium lactis Bifidobacterium lactis and fructooligosaccharide Gelatin

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Louise Crovesy de Oliveira

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise C Oliveira, MD student

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Louise Crovesy de Oliveira

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 33565558 (View on PubMed)

Related Links

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http://www.nutricao.ufrj.br/

Institute of Nutrition Josué de Castro

Other Identifiers

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CEP 104-14

Identifier Type: -

Identifier Source: org_study_id