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NCT Number: NCT07596992

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Change of inflammatory status in the participants

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Mafra

CONTACT

[email protected]

+5521985683003

Ludmila Cardozo

CONTACT

[email protected]

+5521987333185

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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