Obesity
Conditions
Interventions
Randomized, double-blind, phase II, placebo-controlled clinical trial that will involve obese women (BMI =35 kg/m²) enrolled in the Bariatric Surgery Program (ProBari) of the Professor Alberto Antunes
Sponsors
Universidade Federal de Alagoas
Hospital Universiário Professor Alberto Antunes
Eligibility
Sex/Gender
Female
Age
19 Years to 40 Years
Inclusion criteria
Inclusion criteria: Women; between 19 and 40 years of age; obese (Body Mass Index greater than 35 kg/m^2); enrolled in the Bariatric Surgery Program at the Prof. Alberto Antunes University Hospital, Maceió, Alagoas
Exclusion criteria
Exclusion criteria: Being pregnant or lactating; making use of psychotropic drugs; having undergone recent surgery (last 6 months); being allergic to bee products and; living in a municipality outside the metropolitan region of Maceió (due to the difficulty of moving to the research location)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that after 12 weeks of supplementation it will be possible to detect a clinically relevant and statistically significant difference in fasting glycemia between participants in the intervention and placebo groups. Blood samples will be collected, under fasting conditions, by professionals from the technical staff of the Laboratory of Clinical Analysis/Hospital Universitário Prof. Alberto Antunes (Laboratory/HUPAA), where the analyzes will be carried out. Venous blood will be obtained using separator gel tubes and EDTA anticoagulant tubes. Dosing will be performed on Architect c8000 equipment using Abbott kits. The chemiluminescence method will be used. The Laboratory/HUPAA has a certificate of excellence provided by the National Quality Control Program (PNCQ)/Brazilian Society of Clinical Analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The composition of propolis contains some antioxidant constituents, which is why it will be investigated whether its supplementation alters the biochemical pattern indicative of oxidative stress. For this, the following markers will be analyzed: malondialdehyde and glutathione reductase by Elisa test (Cell Biology Laboratory of the Institute of Biological and Health Sciences at UFAL) and oxidized LDL (private laboratory);To test the hypothesis that propolis supplementation promotes the health of patients, at the end of the 90 days of supplementation, the incidence of illnesses during this intervention period will be compared. The information on this occurrence will be done through a survey of reported morbidity, and the significance of the differences will be analyzed using the chi-square test.;It is expected that the anti-inflammatory and antioxidant effects attributed to propolis can be effective in improving the blood pressure levels of patients, which is why the effects of its supplementation on systolic and diastolic blood pressure will be investigated. Blood pressure will be measured with a column sphygmomanometer, following the Brazilian Guidelines on Arterial Hypertension–2020;The presence of a significant difference in the mean body mass (kg) observed between the experimental and control groups before and after the supplementation period will be analyzed.;At the end of the intervention period, the occurrence of significant changes in the means of the variables related to the patients' body composition (percentage of body fat, lean mass and BMI) will be analyzed, according to the group to which they were allocated. Body composition will be estimated by ultrasound (BodyMetrix – IntelaMetrix, Inc.);At the end of three months of supplementation, the groups will be statistically compared for possible differences related to the evolution of the biochemical profile indicative of changes in carbohydrate metabolism (glycated hemoglobin, insulin, HOMA % ß and HOMA-S) | — |
Countries
Brazil
Contacts
Public ContactHaroldo Ferreira
Universidade Federal de Alagoas
Outcome results
None listed