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

NCT07596992 — Not applicable, Not yet recruiting, 50 participants, Universidade Federal Fluminense

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RegistryNCT07596992
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, health services research
Enrollment50 (Estimated)
SponsorUniversidade Federal Fluminense (Other); collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
ConditionsCoronary Artery Disease (CAD), Oxidative Stress, Inflammation
InterventionsPropolis + Royal Jelly, Placebo (Dietary supplement)
Datesstart 2026-05-18 (estimated), primary completion 2027-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-05-19, last updated 2026-05-19
Locations1 site in Brazil

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Propolis + Royal jelly GroupExperimentalDietary Supplement: Propolis + Royal JellyThey will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.
Placebo GroupPlacebo comparatorDietary Supplement: PlaceboThey 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).
  • Propolis + Royal Jelly (Dietary supplement): They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.
  • Placebo (Dietary supplement): 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).

+Outcome measures

Primary outcomes

  • 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).

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Denise mafraNiterói, Rio de JaneiroBrazil

+Investigators

My Notes