Obesity
Conditions
Keywords
Obesity, Probiotic, Symbiotic, Weight loss, Gut microbiota, Bifidobacterium lactis, Fructooligosaccharide, Blood sugar, Lipemia, Metabolome
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
DIETARY_SUPPLEMENTSymbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
DIETARY_SUPPLEMENTPlacebo
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Sponsors
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Universidade Federal do Rio de Janeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 |
Countries
Brazil
Outcome results
None listed