Effects of Royal Jelly and Propolis on Metabolomic Signatures, Inflammation, and Cardiovascular Risk in Patients With Coronary Artery Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propolis + Royal Jelly, Placebo.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD), Oxidative Stress, Inflammation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Several sources of bioactive compounds have been studied due to their protective effect against coronary artery disease (CAD), mainly by modulating inflammation and oxidative stress. Among them, propolis stands out, rich in flavonoids and phenolic acids, which exhibits antioxidant and anti-inflammatory activity; and royal jelly, containing bioactive peptides that promote endothelial function and have an anti-inflammatory effect, potentially contributing to the prevention of CAD progression. Regular consumption of these foods may represent a complementary therapeutic strategy for CAD prevention.
Interventions
- Dietary supplement Propolis + Royal Jelly
They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day. - Dietary supplement Placebo
They 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).
Primary outcome measures
- Change of inflammatory status in the participants [Time frame: Baseline and 8 weeks]
Eligibility criteria
Inclusion criteria
- 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;
- Patients who have already undergone coronary revascularization and angioplasty may participate;
- the last acute coronary event must have occurred more than one year ago.
Exclusion criteria
- Unstable Coronary Artery Disease;
- Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;
- Unstable angina;
- NYHA functional class III or higher;
- Advanced chronic kidney disease (creatinine clearance < 30 ml/min/1.73 m²);
- Individuals with autoimmune diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
Brazil · 1 center
- Denise mafra — Niterói
Identifiers
NCT: NCT07596992 · Denise Mafra_DAC2