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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal Fluminense

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Unstable Coronary Artery Disease;

Pre-operative coronary artery bypass grafting or awaiting elective angioplasty;

Unstable angina;

NYHA functional class III or higher;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Propolis + Royal jelly GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal Fluminense

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Collaborator

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