Clinical trial NCT02505854: Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
Official title: Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Probiotic
Symbiotic
Weight loss
Gut microbiota
Bifidobacterium lactis
Fructooligosaccharide
Blood sugar
Lipemia
Metabolome
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2015-07-22
Enrollment: 32
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effect of probiotic and symbiotic on weight loss of women obese
timeFrame: Baseline and 60 days and 15 days after the end of the intervention
Secondary outcomes:
measure: Effect of probiotic and symbiotic on blood glucose
timeFrame: Baseline, 60 days and 15 days after the end of the intervention
measure: Effect of probiotic and symbiotic on insulin resistance
timeFrame: Baseline and 60 days
measure: Effect of probiotic and symbiotic on lipid profile
timeFrame: Baseline and 60 days
measure: Effect probiotic and symbiotic on blood pressure
timeFrame: Baseline,60 days and 15 days after intervention conclusion
measure: Effect of probiotic and symbiotic on gut microbiota composition
timeFrame: Baseline, 60 days and 15 days after intervention conclusion
measure: Effect of probiotic and symbiotic on stool consitency by Bristol scale
timeFrame: Baseline,60 days and 15 days after intervention conclusion
measure: Effect of probiotic and symbiotic on gastrointestinal symptons
timeFrame: Baseline,60 days and 15 days after intervention conclusion
measure: Effect of probiotic and symbiotic on metabolomic profile
timeFrame: Baseline and 60 days
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Louise Crovesy de Oliveira
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Louise C Oliveira, MD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.