Effects of Royal Jelly and Propolis on Metabolomic Signatures, Inflammation, and Cardiovascular Risk in Patients With Coronary Artery Disease.

Universidade Federal Fluminense

Status: Not yet enrolling

Conditions: Inflammation; Oxidative Stress; Coronary Artery Disease (CAD)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Propolis + Royal Jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT07596992

Denise Mafra_DAC2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Propolis + Royal jelly Group

Experimental group

Description:

They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.

Treatment:

Dietary Supplement: Propolis + Royal Jelly

Placebo Group

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo