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

Study Overview
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Symbiotic
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin | Dietary Supplement: Probiotic<br>* Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin<br>* Other names: Bifidobacterium lactis;|
| Active Comparator: Symbiotic<br>Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide | Dietary Supplement: Symbiotic<br>* Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide<br>* Other names: Bifidobacterium lactis and fructooligosaccharide;|
| Placebo Comparator: Placebo<br>Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin | Dietary Supplement: Placebo<br>* Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin<br>* Other names: Gelatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota, Obesity, Probiotic, Symbiotic, Weight loss, Bifidobacterium lactis, Fructooligosaccharide, Blood sugar, Lipemia, Metabolome