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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07596992

Enrollment

Registered

2026-05-19

Start date

2026-05-18

Completion date

2028-12-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD), Inflammation, Oxidative Stress

Keywords

royal jelly, propolis, coronary artery disease, oxidative stress, inflammation

Brief summary

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_SUPPLEMENTPropolis + 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_SUPPLEMENTPlacebo

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change of inflammatory status in the participants	Baseline and 8 weeks	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).

Countries

Brazil

Contacts

CONTACTDenise Mafra

dmafra30@gmail.com+5521985683003

CONTACTLudmila Cardozo

ludmilacardozo@id.uff.br+5521987333185

PRINCIPAL_INVESTIGATORLudmila Cardozo

Universidade Federal Fluminense

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026