About this trial
The aim of this project is to evaluate the effect of bioactive compound sources, propolis and royal jelly, on metabolomics, inflammation, and cardiovascular risk markers in participants with coronary artery disease. A longitudinal double-blind randomized clinical trial will be carried out, involving CAD participants for two months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both sexes
Over 18 years of age;
Diagnosed with Coronary Artery Disease: confirmed by coronary angiography, coronary computed tomography angiography, or functional testing with ischemic load);
Participants who are asymptomatic or have angina limited to functional class III will be considered;
Disqualifiers
Unstable Coronary Artery Disease;
Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;
Unstable angina;
NYHA functional class III or higher;
Trial design
Parallel
Treatments tested in this trial
Propolis + Royal Jelly
Dietary supplementThey will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.
Placebo
Dietary supplementThey will receive 4 capsules per day, providing daily delivery of the active formulation vehicle (microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal contents).
Treatment groups
Trial outcomes
Primary outcomes
Change of inflammatory status in the participants
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
Sponsors and contacts
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Universidade Federal Fluminense
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Collaborator
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