Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propolis associated with Royal Jelly, Royal Jelly, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Hypertension, Cardiovascular Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association of Green Propolis Extract and Royal Jelly to Modulate Inflammation and Oxidative Stress in Hypertensive Patients and/or With Chronic Kidney Disease
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Propolis associated with Royal Jelly
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. - Dietary supplement Royal Jelly
The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months. - Dietary supplement Placebo
The participant will consume 4 capsules a day of placebo, for 2 months.
Primary outcome measures
- Change in factor nuclear kappaB [Time frame: Baseline and 8 weeks (2 months)]
- Change in intestinal microbiota [Time frame: Baseline and 8 weeks (2 months)]
Secondary outcome measures (2)
- Change in senescence biomarkers [Time frame: Baseline and 8 weeks (2 months)]
- Change in uremic toxins [Time frame: Baseline and 8 weeks (2 months)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- autoimmune and infectious diseases,
- diabetes
- cancer
- AIDS
- pregnant women
- patients using catabolic drugs or antibiotics;
- patients with catheter access to hemodialysis;
- patients using antioxidant vitamin supplements, prebiotics, probiotics, symbiotic,
- Patients on regular intake of propolis who are allergic to corn starch or report being allergic to bee stings.
- patients with acute myocardial infarction (AMI) and/or cerebrovascular accident (CVA)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
Brazil · 2 centers
- Denise Mafra — Rio de Janeiro
- Denise Mafra — Rio de Janeiro
Identifiers
NCT: NCT06288204 · Denise Mafra16