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The study aims to evaluate the effect of the royal jelly 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) is considered a 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 highlight its 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 in human populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Royal Jelly Group | Experimental | Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks). |
|
| Placebo Group | Placebo Comparator | The placebo group will receive 2 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 |
|---|---|---|---|---|
| Royal Jelly | Dietary Supplement | Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of inflammatory transcripton factor | Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in interleukin-6 (IL-6) levels | Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation. | Baseline and 8 weeks |
| Change in tumor necrosis factor-alpha (TNF-α) levels |
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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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Recruiting | Rio de Janeiro | Rio de Janeiro | 22260050 | Brazil |
Participant data will not be public to other research unless necessary.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C058787 | royal jelly |
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| Placebo | Dietary Supplement | The placebo group will receive 2 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. |
|
Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation.
| Baseline and 8 weeks |
| Change in Nrf2 expression | Assessment of changes in Nrf2 expression after supplementation. | Baseline and 8 weeks |
| Change in C-reactive protein (CRP) levels | Assessment of changes in serum C-reactive protein (CRP) levels after supplementation. | Baseline and 8 weeks |
| Change in antioxidant enzyme activity | Assessment of changes in antioxidant enzyme activity after supplementation. | Baseline and 8 weeks |