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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
34
Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
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.
Denise Mafra
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGChange of inflammatory transcripton factor
Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.
Time frame: Baseline and 8 weeks
Change in interleukin-6 (IL-6) levels
Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation.
Time frame: Baseline and 8 weeks
Change in tumor necrosis factor-alpha (TNF-α) levels
Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation.
Time frame: Baseline and 8 weeks
Change in Nrf2 expression
Assessment of changes in Nrf2 expression after supplementation.
Time frame: Baseline and 8 weeks
Change in C-reactive protein (CRP) levels
Assessment of changes in serum C-reactive protein (CRP) levels after supplementation.
Time frame: Baseline and 8 weeks
Change in antioxidant enzyme activity
Assessment of changes in antioxidant enzyme activity after supplementation.
Time frame: Baseline and 8 weeks
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