Pediatric Obesity
Conditions
Interventions
Intervention Group: 14 adolescents from 10 to 19 years old will receive a probiotic mix containing Lactobacillus acidophilus LA-5® and Bifidobacterium lactis BB-12®, containing 1 x 10^9 CFU (Colonies
Dietary supplement
G07.203.300.456.500
Sponsors
Escola Bahiana de Medicina e Saúde Pública
Delphin Medicina DIagnóstica
Centro de Pesquisas Gonçalo Moniz - Fiocruz/BA
Eligibility
Age
10 Years to 19 Years
Inclusion criteria
Inclusion criteria: Adolescents between 10 to 19 years old; Diagnosis of obesity, based on the BMI/age indicator above +2 z scores of the WHO reference curve; Previous ultrasound diagnosis of Non-Alcoholic Fatty Liver Disease; Signature of the Review Board Authorization Form; Previous history of attendance to the service (absence of absences in the previous year); Absence of diabetes mellitus (fasting blood glucose below 100 mg/dl); Living in Salvador or metropolitan urban area;
Exclusion criteria
Exclusion criteria: Presence of endogenous obesity; Presence of psychiatric comorbidity or disease that interferes with weight evolution; Use of medications such as metformin, statins, laxatives, antibiotics, antidepressants, corticosteroids, anxiolytics and / or any other medication that may interfere with the gut microbiota; Be classified as SGA (Small for Gestational Age) at birth;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find at least a reduction of 15% in liver fat percent obtained by nuclear magnetic resonance (PDFF method - Proton Density Fat Fraction);It is expected to find a reduction in Insulin resistance, quantified by a minimum decrease of 20% in the HOMA-IR index pre- and post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction of at least 20% in the seric values of AST, ALT and GGT pre- and post-intervention.;It is expected to find a reduction of at least 20% in the ferritin serum levels pre- and post-intervention.;It is expected to find a minimum decrease of 20% in the circulating interleukins levels (tumor necrosis factor-alpha - TNF-alpha, Interleukin 2 and 6 - IL-2 and IL-6) pre- and post-intervention.;It is expected to find a minimum decrease of 20% in the serum levels of adiponectin pre- and post-intervention. | — |
Countries
Brazil
Contacts
Public ContactNey Boa-Sorte
Escola Bahiana de Medicina e Saúde Pública
Outcome results
None listed