Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Federal Fluminense
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients in stages 3 and 5 of CKD (GFR from 15 to 59 mL/min),
patients receiving ambulatorial nutrition treatment at least 6 months
patients on regular Hemodialysis treatment for at least 6 months
patients using one to three antihypertensive drugs
Disqualifiers
autoimmune and infectious diseases,
diabetes
cancer
AIDS
Trial design
Design model
Parallel
Treatments tested in this trial
Propolis associated with Royal Jelly
Dietary supplementThe 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.
Royal Jelly
Dietary supplementThe participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
Placebo
Dietary supplementThe participant will consume 4 capsules a day of placebo, for 2 months.
Treatment groups
153 Participants
are divided into 3 treatment groupsGroup A: Propolis associated with Royal Jelly GroupExperimental treatment 1 intervention
Group B: Royal JellyExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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)2
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)Secondary outcomes
1
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)2
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)Other outcomes
1
Change in adhesion molecules
Get blood samples to evaluate the supplementation effects Vascular Cell Adhesion Molecule (VCAM).
Time frame
Baseline and 8 weeks (2 months)2
Change in blood pressure
Evaluate at baseline and 8 weeks the Systolic or Diastolic Blood Pressure
Time frame
Baseline and 8 weeks (2 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade Federal Fluminense
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Collaborator
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Source ClinicalTrials.gov