Chronic Kidney DiseasesNCT06288204
Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease
A study testing Propolis associated with Royal Jelly and Royal Jelly in people with Chronic Kidney Diseases and Hypertension, run by Universidade Federal Fluminense at 2 sites in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension, Cardiovascular Diseases
- What is being tested?
- Propolis associated with Royal Jelly and Royal Jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- autoimmune and infectious diseases,
- diabetes
- cancer
- AIDS
- pregnant women
- patients using catabolic drugs or antibiotics;
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050
Denise Mafra, phd, 21985683003, dmafra30@gmail.com
- Recruiting
Denise Mafra
Rio de Janeiro, Rio de Janeiro
Denise Mafra, 5521985683003, dmafra30@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- Propolis associated with Royal Jelly, Royal Jelly, Placebo
- Keywords
- chronic kidney disease, hypertension, cardiovascular disease, inflammation, oxidative stress, green propolis, royal jelly, Nrf2, Nuclear factor kappa-B
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis associated with Royal JellyDietary supplement
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.
Royal JellyDietary supplement
The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
PlaceboDietary supplement
The participant will consume 4 capsules a day of placebo, for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Propolis associated with Royal Jelly Group | Experimental | 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. Receives: Dietary Supplement: Propolis associated with Royal Jelly |
| Royal Jelly | Experimental | Royal Jelly will receive 1 capsule a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months. Receives: Dietary Supplement: Royal Jelly |
| Placebo | Placebo comparator | 4 capsules a day of placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in factor nuclear kappaB
Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.
Measured: 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.
Measured: Baseline and 8 weeks (2 months)
Secondary outcomes (2)
Change in senescence biomarkers
Get blood samples to evaluate the supplementation effects in p14, p16, p21, p53.
Measured: Baseline and 8 weeks (2 months)
Change in uremic toxins
Get blood samples to evaluate the supplementation effects in p-cresyl sulfate (p-CS)
Measured: Baseline and 8 weeks (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
- Investigators
- Denise Mafra, PhD, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288204
- Sponsor's protocol ID
- Denise Mafra16
- Status last verified
- May 2026
- First submitted
- 23 Feb 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be public to other research unless necessary.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06288204
- Acronym / sponsor ID
- Denise Mafra16
- Keywords
- chronic kidney disease, hypertension, cardiovascular disease, inflammation, oxidative stress, green propolis, royal jelly, Nrf2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propolis associated with Royal Jelly Group | Experimental | Dietary Supplement: Propolis associated with Royal Jelly4 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 | Experimental | Dietary Supplement: Royal JellyRoyal Jelly will receive 1 capsule a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 capsules a day of placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- autoimmune and infectious diseases,
- diabetes
- cancer
- AIDS
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolis associated with Royal JellyThe 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 | Propolis associated with Royal Jelly Group |
| Royal JellyThe participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months. | Dietary supplement | Royal Jelly |
| PlaceboThe participant will consume 4 capsules a day of placebo, for 2 months. | Dietary supplement | Placebo |
Primary outcome
Change in factor nuclear kappaB
Time frame: Baseline and 8 weeks (2 months)
Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.
Change in intestinal microbiota
Time frame: Baseline and 8 weeks (2 months)
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.
2 secondary outcomes
Change in senescence biomarkers
Time frame: Baseline and 8 weeks (2 months)
Change in uremic toxins
Time frame: Baseline and 8 weeks (2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Participant data will not be public to other research unless necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denise Mafra, PhD principal investigator
Universidade Federal Fluminense
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis associated with Royal Jelly and Royal Jelly in people with Chronic Kidney Diseases and Hypertension, run by Universidade Federal Fluminense at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Mafra, PhD (5521985683003, dmafra30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in factor nuclear kappaB (time frame: Baseline and 8 weeks (2 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.