Kidney Failure, ChronicNCT06438445
Effects of Royal Jelly Supplementation in Chronic Kidney Disease
A study testing Real Jelly in people with Kidney Failure, Chronic and Oxidative Stress, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Failure, Chronic, Oxidative Stress, Hemodialysis
- What is being tested?
- Real Jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2024to 5 Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with CKD undergoing hemodialysis for more than 6 months
- patients with arteriovenous fistula (AVF) as vascular access.
Who cannot join
- pregnant,
- lactating,
- smoker
- patients using antibiotics and antioxidant supplements in the last three months
- patients with autoimmune and infectious diseases,
- patients with cancer, liver disease, and AIDS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050
Denise Mafra, phd, 21985683003, dmafra30@gmail.com
About this study
Official title: Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis
The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).
Read the detailed description
Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed.
- Conditions
- Kidney Failure, Chronic, Oxidative Stress, Hemodialysis
- Being tested
- Real Jelly, Placebo
- Keywords
- Cellular Senescence, Renal Dialysis, Renal Insufficiency, Chronic, Oxidative Stress
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real JellyDietary supplement
Participants will receive 500mg of royal jelly capsules per day for two months.
PlaceboDietary supplement
Participants will receive 500mg of placebo capsules per day for two months.
| Study group | Role | What they receive |
|---|---|---|
| Real Jelly Group | Experimental | Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of royal jelly/day for two months. Receives: Dietary Supplement: Real Jelly |
| Placebo group | Placebo comparator | Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of placebo/ day for two months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory biomarkers
Changes in the mRNA levels of Nrf2, Keap1, Bach1, NLPR3, NF-kB, HO-1, NQO1, p14, p16, p21 and p53 as well as VCAM, ICAM and E-selectin and TLR-4, TNFR and AhR receptors, which will be evaluated from peripheral blood mononuclear cells.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start30 Jul 2024
- Primary completion22 Dec 2026 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Mafra, Study director, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438445
- Sponsor's protocol ID
- Interventional
- Status last verified
- May 2026
- First submitted
- 27 May 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis
- ClinicalTrials.gov ID
- NCT06438445
- Acronym / sponsor ID
- Interventional
- Conditions
- Kidney Failure, Chronic, Oxidative Stress, Hemodialysis
- Keywords
- Cellular Senescence, Renal Dialysis, Renal Insufficiency, Chronic, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 31 May 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.
The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).
Detailed description
Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed.
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
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Jelly Group | Experimental | Dietary Supplement: Real JellyPatients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of royal jelly/day for two months. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPatients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of placebo/ day for two months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with CKD undergoing hemodialysis for more than 6 months
- patients with arteriovenous fistula (AVF) as vascular access.
Key exclusion criteria (6 listed)
- pregnant,
- lactating,
- smoker
- patients using antibiotics and antioxidant supplements in the last three months
- patients with autoimmune and infectious diseases,
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 |
|---|---|---|
| Real JellyParticipants will receive 500mg of royal jelly capsules per day for two months. | Dietary supplement | Real Jelly Group |
| PlaceboParticipants will receive 500mg of placebo capsules per day for two months. | Dietary supplement | Placebo group |
Primary outcome
Change in inflammatory biomarkers
Time frame: 6 weeks
Changes in the mRNA levels of Nrf2, Keap1, Bach1, NLPR3, NF-kB, HO-1, NQO1, p14, p16, p21 and p53 as well as VCAM, ICAM and E-selectin and TLR-4, TNFR and AhR receptors, which will be evaluated from peripheral blood mononuclear cells.
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 18 May 2026.
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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 study director
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Jelly in people with Kidney Failure, Chronic and Oxidative Stress, run by Universidade Federal Fluminense at 1 site 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 2 inclusion and 6 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 18 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 1 site 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 (21985683003, 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 inflammatory biomarkers (time frame: 6 weeks). 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 18 May 2026.