This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with chronic kidney diseases (CKD) and Systemic arterial hypertension (SAH), in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.
Propolis and royal jelly are bee products. Propolis is a resinous mixture produced by bees with their saliva and the addition of wax, from exudates collected from buds and plant sap. Royal jelly is a substance produced in the hypopharyngeal glands of young worker bees. Both products are rich in bioactive compounds such as polyphenols. The combination of propolis extract and royal jelly, substances constituted by the combination of several chemical components with potential biological activity, may emerge as a promising adjuvant therapeutic alternative for patients with CKD and SAH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
153
The participants will consume 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis together, for 2 months.
The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
The participant will consume 4 capsules a day of placebo, for 2 months.
Denise Mafra
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGDenise Mafra
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGChange in factor nuclear kappaB
Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.
Time frame: Baseline and 8 weeks (2 months)
Change in intestinal microbiota
Stool samples will be collected to evaluate the taxa of bacteria colonizing the intestinal microbiota through short-read sequencing of the V4 region of the RNA ribosomal (rRNA) gene on the Illumina platform.
Time frame: Baseline and 8 weeks (2 months)
Change in senescence biomarkers
Get blood samples to evaluate the supplementation effects in p14, p16, p21, p53.
Time frame: Baseline and 8 weeks (2 months)
Change in uremic toxins
Get blood samples to evaluate the supplementation effects in p-cresyl sulfate (p-CS)
Time frame: Baseline and 8 weeks (2 months)
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