Cardiovascular Diseases (CVD), Hypertension, Inflammation
Conditions
Keywords
royal jelly, inflammation, Hypertension, cardiovascular diseases
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTRoyal Jelly
Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage 1 hypertension * Regular treatment for more than 6 months * No changes in medication doses during the last 3 months
Exclusion criteria
* Autoimmune diseases * Infectious diseases * Diabetes * Chronic kidney disease * Liver disease * Cancer * AIDS * Pregnant women * Use of catabolic drugs or antibiotics * Use of antioxidant vitamin supplements, prebiotics, probiotics, or synbiotics * Habitual intake of royal jelly * Allergy to bee stings * Acute myocardial infarction (AMI) * Stroke (CVA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of inflammatory transcripton factor | Baseline and 8 weeks | Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in interleukin-6 (IL-6) levels | Baseline and 8 weeks | Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation. |
| Change in tumor necrosis factor-alpha (TNF-α) levels | Baseline and 8 weeks | Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation. |
| Change in Nrf2 expression | Baseline and 8 weeks | Assessment of changes in Nrf2 expression after supplementation. |
| Change in C-reactive protein (CRP) levels | Baseline and 8 weeks | Assessment of changes in serum C-reactive protein (CRP) levels after supplementation. |
| Change in antioxidant enzyme activity | Baseline and 8 weeks | Assessment of changes in antioxidant enzyme activity after supplementation. |
Countries
Brazil
Contacts
CONTACTDenise mafra, PhD
PRINCIPAL_INVESTIGATORLudmila Cardozo, PhD
Universidade Federal Fluminense
Outcome results
None listed