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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis + Royal jelly Group | Experimental | They will receive 4 capsules per day, providing 300 mg of royal jelly per day and 500 mg of propolis per day. |
|
| Placebo Group | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denise Mafra | Contact | +5521985683003 | dmafra30@gmail.com | |
| Ludmila Cardozo | Contact | +5521987333185 | ludmilacardozo@id.uff.br |
| Name | Affiliation | Role |
|---|---|---|
| Ludmila Cardozo | Universidade Federal Fluminense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise mafra | Niterói | Rio de Janeiro | 24220-900 | Brazil |
Participant data will not be public to other research unless necessary.
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| 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). |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| C058787 | royal jelly |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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