Inflammation, Systemic Arterial Hypertension
Conditions
Keywords
inflammation, royal jelly, propolis, hypertension, oxidative stress
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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.
DIETARY_SUPPLEMENTRoyal Jelly + Propolis Group
Participants will receive 4 capsules per day, providing the dosage of 300mg of royal jelly + 500mg propolis for 2 months (8 weeks).
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 and 2 hypertension * Regular treatment for more than 6 months * There have been no changes in medication doses over the last three months.
Exclusion criteria
* Autoimmune and infectious diseases, diabetes * Chronic kidney disease, liver disease, cancer and AIDS * Pregnant women * Use of catabolic drugs or antibiotics * Use of antioxidant vitamin supplements, prebiotics, probiotics, symbiotic * Habitual intake of royal jelly and propolis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of inflammatory citokynes | Baseline and 2 months | 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) |
Countries
Brazil
Contacts
CONTACTDenise Mafra, PhD
STUDY_DIRECTORLudmila Cardozo, PhD
Universidade Federal Fluminense
Outcome results
None listed