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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Louise Crovesy de Oliveira
Rio de Janeiro, Brazil
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.
Time frame: Baseline and 60 days and 15 days after the end of the intervention
Effect of probiotic and symbiotic on blood glucose
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
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.
Time frame: 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.
Time frame: Baseline and 60 days
Effect probiotic and symbiotic on blood pressure
Determine blood pressure and evaluate whether the intervention improvement blood pressure.
Time frame: 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
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 60 days