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

Sponsor

Universidade Federal do Rio de Janeiro (Other)

Overall Status

Completed

CT.gov ID

NCT02505854

Collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ) (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Probiotic Dietary Supplement: Symbiotic Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Evaluate the effect of probiotic and symbiotic on weight loss of women obese [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.

Secondary Outcome Measures

Effect of probiotic and symbiotic on blood glucose [Baseline, 60 days and 15 days after the end of the intervention]
Determine and comparing the blood glucose in plasma before and after intervention
Effect of probiotic and symbiotic on insulin resistance [Baseline and 60 days]
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 [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.
Effect probiotic and symbiotic on blood pressure [Baseline,60 days and 15 days after intervention conclusion]
Determine blood pressure and evaluate whether the intervention improvement blood pressure.
Effect of probiotic and symbiotic on gut microbiota composition [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
Effect of probiotic and symbiotic on stool consitency by Bristol scale [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.
Effect of probiotic and symbiotic on gastrointestinal symptons [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.
Effect of probiotic and symbiotic on metabolomic profile [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.