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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Oxidative Stress; Coronary Artery Disease (CAD)
• Intervention / Treatment: Dietary supplement: Propolis + Royal Jelly; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denise Mafra; Phone Number: +5521985683003; Email: dmafra30@gmail.com
• Study Contact Backup: Name: Ludmila Cardozo; Phone Number: +5521987333185; Email: ludmilacardozo@id.uff.br

Study Locations

• Brazil
  • Rio de Janeiro
    • Niterói, Rio de Janeiro, Brazil, 24220-900
      • Denise Mafra
      • Contact: Ludmila Cardozo; Phone Number: +5521987333185; Email: ludmilacardozo@id.uff.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propolis + Royal jelly Group; They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day.	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.
Placebo Comparator: Placebo Group; 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Principal Investigator: Ludmila cardozo, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; inflammation; oxidative stress; propolis; royal jelly
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Inflammation; Coronary Artery Disease; Polymers; Macromolecular Substances; Biological Products; Complex Mixtures; Biopolymers; Plant Exudates; Resins, Plant; Propolis; royal jelly
• Other Study ID Numbers: Denise Mafra_DAC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be public to other research unless necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No