Cardiovascular Diseases
Conditions
Interventions
This project is characterized as a double-blind randomized cohort clinical study. The sample size was calculated using the formula n = [(Z2 * p * q) / e2] for a maximum error of 10%, where Z = Degree
it was not possible to obtain a blood sample for biochemical measurements at the beginning and/or end of the study
presented
Sponsors
Universidade Regional de Blumenau
Universidade Regional de Blumenau
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects over 18 years of age from both genders who agree to participate by signing the informed consent form; answer questions from the anamnesis questionnaire and anthropometric data; make a daily intake of propolis extract or placebo during the study; and provide a sample of blood for biochemical measurements at the beginning and at the end of the study
Exclusion criteria
Exclusion criteria: Do not take a daily intake of of propolis extract or placebo during the study; not possible to obtain a blood sample for the biochemical measurements at the beginning and at the end of the study; presented as women pregnant or breastfeeding women; history of malabsorption or gastrointestinal surgery; cognitive problems that prevent them from understanding the instructions for participating in the study; participating in another clinical study at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome found 14: Regardless of the type of propolis ingested, we observed an increase in the sulfhydryl content in the population studied. Analyzing them separately, with the propolis of A. melífera and M. quadrifasciata there was an increase in the sulfhydryl content;Expected outcome 1: statistically or clinically significant (considering reference values) changes after 90 days in fasting blood glucose levels;Outcome found 1: no statistically or clinically significant changes (considering the reference values) were found after 90 days in fasting blood glucose levels;Expected outcome 2: statistically or clinically significant changes (considering reference values) after 90 days in blood levels of glycated hemoglobin;Outcomefound 2: No statistically or clinically significant changes (considering the reference values) were found after 90 days in blood levels of glycated hemoglobin;Expected outcome 3: statistically or clinically significant (considering reference values) changes after 90 days in blood cortisol levels;Outcome found 3: no statistically or clinically significant changes (considering the reference values) were found after 90 days in blood cortisol levels;Expected outcome 4: Statistically or clinically significant (from baseline) changes after 90 days in fasting blood insulin levels;Outcome found 4: Regardless of the type of propolis ingested, we observed an increase in fasting insulin levels in the population studied. Analyzing the propolis from A. mellifera in isolation, there was an increase in fasting insulin levels.;Expected outcome 5: statistically or clinically significant changes (considering reference values) after 90 days in glucose homeostasis indices (HOMA-IR and HOMA-Beta);Outcome found 5: Regardless of the type of propolis ingested, we observed an increase in glucose homeostasis indices (HOMA-IR and HOMA-Beta) in the population studied. Analyzing the propolis from A. mellifera in isolation, there was an increase in glucose homeostasis indice | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: statistically or clinically significant changes (considering reference values) after 90 days in serum creatinine levels;Outcome found 1: no statistically or clinically significant changes (considering the reference values) were found after 90 days in blood creatinine levels;Expected outcome 2: statistically or clinically significant changes (considering reference values) after 90 days in serum uric acid levels;Outcome found 2: no statistically or clinically significant changes (considering the reference values) were found after 90 days in blood uric acid levels;Expected outcome 3: statistically or clinically significant changes (considering reference values) after 90 days in serum albumin levels;Outcome found 3: no statistically or clinically significant changes (considering the reference values) were found after 90 days in serum albumin levels;Expected outcome 4: statistically or clinically significant changes (considering reference values) after 90 days in serum bilirubin levels;Outcome found 4: No statistically or clinically significant changes (considering reference values) were found after 90 days in serum bilirubin levels;Expected outcome 5: Statistically or clinically significant changes (considering reference values) after 90 days in serum cholinesterase levels;Outcome found 5: No statistically or clinically significant changes (considering reference values) were found after 90 days in serum cholinesterase levels;Expected outcome 6: Statistically or clinically significant changes (considering reference values) after 90 days in serum gamma-glutamyl transferase (gamma-GT) levels;Outcome found 6: No statistically or clinically significant changes (considering the reference values) were found after 90 days in serum levels of gamma-glutamyl transferase (gamma-GT);Expected outcome 7: Statistically or clinically significant changes (considering reference values) after 90 days in serum alanine aminotransferase (ALT) levels;Outcome found 7: No sta | — |
Countries
Brazil
Contacts
Public ContactCaio Mendes de Cordova
Universidade de Blumenau
Outcome results
None listed