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The study aims to evaluate the effect of the royal jelly and propolis on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.
Royal jelly (RG) and propolis (P) are considered superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR and P highlight their potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly and propolis in human populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Royal Jelly + Propolis Group | Experimental | Participants will receive 4 capsules per day, providing the dosage of 300mg of royal jelly + 500mg propolis for 2 months (8 weeks). |
|
| Placebo Group | Placebo Comparator | The placebo group will receive 4 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | The placebo group will receive 4 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of inflammatory citokynes | Get blood samples to evaluate the supplementation effects in inflammatory cytokines such as interleukin 6 (IL-6, pg/mL), IL-1b (pg/mL), IL-17 (pg/mL) e TNF-α (pg/mL) | Baseline and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denise Mafra, PhD | Contact | +5521985683003 | dmafra30@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ludmila Cardozo, PhD | Universidade Federal Fluminense | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Recruiting | Niterói | Rio de Janeiro | 24220-900 | Brazil |
Participant data will not be public to other research unless necessary.
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| Royal Jelly + Propolis Group | Dietary Supplement | Participants will receive 4 capsules per day, providing the dosage of 300mg of royal jelly + 500mg propolis for 2 months (8 weeks). |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C058787 | royal jelly |
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