Chronic Kidney DiseasesNCT05183737
Effects of Microencapsulated Propolis and Turmeric in Patients With Chronic Kidney Disease
A study testing Microcapsules with turmeric and propolis in people with Chronic Kidney Diseases and Inflammation, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way that they bring several harms to patients, including an increased risk of cardiovascular disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in some foods seem to mitigate inflammation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Kidney Diseases, Inflammation
- What is being tested?
- Microcapsules with turmeric and propolis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Mar 2022to 31 Dec 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with stage 5 CKD (GFR < 15 mL/min);
- On hemodialysis for more than 6 months;
- Who have arteriovenous fistula (AVF) as vascular access
Who cannot join
- Pregnant women;
- Smokers;
- Using antibiotics in the last 3 months;
- Using antioxidant supplements;
- Who have habitual intake of propolis, curcumin and turmeric;
- With autoimmune and infectious diseases, cancer, liver and AIDS (Acquired Immunodeficiency Syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supplementation With Microcapsules of Tumeric and Propolis on Inflammatory Markers in Patients on Hemodialysis
Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way that they bring several harms to patients, including an increased risk of cardiovascular disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in some foods seem to mitigate inflammation. Turmeric and propolis are foods that have compounds with antioxidant and anti-inflammatory capacity, as they promote the activation of nuclear erythroid transcription factor 2 (Nrf2 - responsible for the synthesis of antioxidant enzymes) and inhibit the activity of nuclear factor Kappa B (NF-κB - which increases the synthesis of inflammatory cytokines). This work aims to evaluate the effects of supplementation of associated propolis and turmeric microcapsules on inflammatory markers in patients with CKD undergoing hemodialysis (HD).
Read the detailed description
The so-called Chronic Non-Communicable Diseases (NCDs) have been increasing in incidence. Among these, one can mention Chronic Kidney Disease (CKD). CKD is considered a public health problem and is characterized by an irreversible syndrome resulting from changes in the function or structure of the kidney, which has a progressive evolution.
Oxidative stress is one of the most potent inducers of inflammation, being an imbalance between the production of reactive oxygen species (ROS) and cellular antioxidant capacity, so that such imbalance can influence the activation of the nuclear factor kB (NF-κB), inflammation-associated interleukins, and tumor necrosis factor alpha 4 (TNF-α), which are promoters of cell damage and organic molecules. Patients with CKD on HD showed increased expression of NF-κB and reduced expression of Nrf2, so it is important to perform studies that propose ways to increase the performance of Nrf2, as well as reduce the activation of NF-κB. the performance of propolis and turmeric.
The study aims to evaluate the effects of supplementation of propolis and turmeric microcapsules on inflammatory markers and clinical parameters in patients with chronic kidney disease undergoing hemodialysis.
Sample calculation was performed using the G-Power 3.1 software, with a test power of 80%, considering the expression of NF-κB as the main outcome, significance level of 5% (two-tailed), effect size of 1, 32. The sample obtained consisted of 34 patients (17 in each group).
The proposed clinical study is a longitudinal randomized and double-blind (randomized controlled trial - RCT) where patients will receive capsules containing microencapsulated turmeric and propolis, twice a day, for 12 weeks. The mixture of microcapsules of propolis and turmeric will be distributed to participants in the form of hard gelatine capsules. The placebo group will receive the same amount of capsules, at the same times, containing gum arabic and corn starch. Randomization will be computerized in a 1:1 ratio.
- Anthropometric assessments, food intake, blood collections will be performed at the beginning of the follow-up and in subsequent consultations;
- The analysis of possible adverse effects will be collected through a separate analysis form;
- The assessment of food intake will be performed through the 3-day 24-hour recall;
- The assessment of nutritional status will be performed using anthropometric data;
- Blood samples will be collected in the morning, after fasting for 12 hours, before the dialysis procedure;
- NF-κB expression will be analyzed by means of peripheral blood nuclear cells (PBMCs) using real-time quantitative polymerase chain reaction (qPCR);
- For the measurement of inflammatory cytokines IL-6 and TNF-α, commercial ELISA kits will be used;
- C-reactive protein (CRP) will be determined by chemiluminescence;
- Lipid peroxidation will be estimated by determining thiobarbituric acid reactive substances (TBARS), including MDA, using the modified Ohkawa method;
- The evaluation of the total antioxidant capacity of the plasma will be determined by ELISA;
The effect of supplementation (∆) on each variable will be defined as the subject of the difference between the variable at the end of supplementation with propolis and turmeric and the value of the variable at the end of placebo administration. Statistical analyzes will be performed using SPSS version 22.0.
- Conditions
- Chronic Kidney Diseases, Inflammation
- Being tested
- Microcapsules with turmeric and propolis
- Keywords
- Chronic Kidney Disease, Hemodialysis, Microcapsules, Inflammation, Propolis, Turmeric
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcapsules with turmeric and propolisDietary supplement
Participants will receive microcapsules containing 0.250 milligrams of turmeric 95% curcumin and 0.250 milligrams of green propolis, twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Microcapsules with turmeric and propolis | Active comparator | Participants will receive microcapsules containing 0.250 milligrams of turmeric 95% curcumin and 0.250 milligrams of green propolis Receives: Dietary Supplement: Microcapsules with turmeric and propolis |
| Placebo Group | Placebo comparator | Participants will receive microcapsules containing arabic gum and cornstarch with the same weight and characteristics as the intersecting microcapsules Receives: Dietary Supplement: Microcapsules with turmeric and propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of the supplementation on the expression of transcription factors
Obtain blood samples to assess the effects of supplementation on biomarkers related to inflammation and antioxidant capacity, such as: erythroid nuclear transcription factor 2 (Nrf2) and nuclear factor Kappa B (NF-κB)
Measured: 4 months
The effects of the supplementation on inflammatory cytokines
Get blood samples to evaluate the supplementation effects on cytokines (IL-6, TNF-α)
Measured: 4 months
Secondary outcomes (1)
The effects of supplementation on CRP levels
Measure before and after supplementation the levels of C-Reactive Protein (mg/dL)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start7 Mar 2022
- Primary completion1 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- The study is a longitudinal randomized, double-blind, placebo-controlled clinical trial with patients with CKD undergoing hemodialysis. Patients will be randomized and divided into two groups: intervention group, which will receive microcapsules containing 250mg of propolis and 250mg of turmeric, twice a day, for 12 weeks, and placebo group, which will receive for the same amount of capsules containing arabic gum and cornstarch.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Mafra, phd, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183737
- Sponsor's protocol ID
- DeniseMafra13
- Status last verified
- Apr 2025
- First submitted
- 11 Aug 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nascimento D, Britto I, Couto H, Alvarenga L, Cardozo LFMF, Berretta AA, Ribeiro-Alves M, da Cunha DF, de Almeida CORP, Lemos I, Guerra MMG, Costa MES, Nakao LS, Teodoro AJ, Mafra D. Effects of a Functional Food Mixture on Patients Undergoing Hemodialysis: Preliminary Results Highlighting the Modulation of Uremic Toxins Derived From Microbiota and Antioxidant Markers. Mol Nutr Food Res. 2025 Jul;69(14):e70083. doi: 10.1002/mnfr.70083. Epub 2025 Apr 28.
PubMed 40296308
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplementation With Microcapsules of Tumeric and Propolis on Inflammatory Markers in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT05183737
- Acronym / sponsor ID
- DeniseMafra13
- Conditions
- Chronic Kidney Diseases, Inflammation
- Keywords
- Chronic Kidney Disease, Hemodialysis, Microcapsules, Inflammation, Propolis, Turmeric
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jan 2022 (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.
Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way that they bring several harms to patients, including an increased risk of cardiovascular disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in some foods seem to mitigate inflammation. Turmeric and propolis are foods that have compounds with antioxidant and anti-inflammatory capacity, as they promote the activation of nuclear erythroid transcription factor 2 (Nrf2 - responsible for the synthesis of antioxidant enzymes) and inhibit the activity of nuclear factor Kappa B (NF-κB - which increases the synthesis of inflammatory cytokines). This work aims to evaluate the effects of supplementation of associated propolis and turmeric microcapsules on inflammatory markers in patients with CKD undergoing hemodialysis (HD).
Detailed description
The so-called Chronic Non-Communicable Diseases (NCDs) have been increasing in incidence. Among these, one can mention Chronic Kidney Disease (CKD). CKD is considered a public health problem and is characterized by an irreversible syndrome resulting from changes in the function or structure of the kidney, which has a progressive evolution.
Oxidative stress is one of the most potent inducers of inflammation, being an imbalance between the production of reactive oxygen species (ROS) and cellular antioxidant capacity, so that such imbalance can influence the activation of the nuclear factor kB (NF-κB), inflammation-associated interleukins, and tumor necrosis factor alpha 4 (TNF-α), which are promoters of cell damage and organic molecules. Patients with CKD on HD showed increased expression of NF-κB and reduced expression of Nrf2, so it is important to perform studies that propose ways to increase the performance of Nrf2, as well as reduce the activation of NF-κB. the performance of propolis and turmeric.
The study aims to evaluate the effects of supplementation of propolis and turmeric microcapsules on inflammatory markers and clinical parameters in patients with chronic kidney disease undergoing hemodialysis.
Sample calculation was performed using the G-Power 3.1 software, with a test power of 80%, considering the expression of NF-κB as the main outcome, significance level of 5% (two-tailed), effect size of 1, 32. The sample obtained consisted of 34 patients (17 in each group).
The proposed clinical study is a longitudinal randomized and double-blind (randomized controlled trial - RCT) where patients will receive capsules containing microencapsulated turmeric and propolis, twice a day, for 12 weeks. The mixture of microcapsules of propolis and turmeric will be distributed to participants in the form of hard gelatine capsules. The placebo group will receive the same amount of capsules, at the same times, containing gum arabic and corn starch. Randomization will be computerized in a 1:1 ratio.
- Anthropometric assessments, food intake, blood collections will be performed at the beginning of the follow-up and in subsequent consultations;
- The analysis of possible adverse effects will be collected through a separate analysis form;
- The assessment of food intake will be performed through the 3-day 24-hour recall;
- The assessment of nutritional status will be performed using anthropometric data;
- Blood samples will be collected in the morning, after fasting for 12 hours, before the dialysis procedure;
- NF-κB expression will be analyzed by means of peripheral blood nuclear cells (PBMCs) using real-time quantitative polymerase chain reaction (qPCR);
- For the measurement of inflammatory cytokines IL-6 and TNF-α, commercial ELISA kits will be used;
- C-reactive protein (CRP) will be determined by chemiluminescence;
- Lipid peroxidation will be estimated by determining thiobarbituric acid reactive substances (TBARS), including MDA, using the modified Ohkawa method;
- The evaluation of the total antioxidant capacity of the plasma will be determined by ELISA;
The effect of supplementation (∆) on each variable will be defined as the subject of the difference between the variable at the end of supplementation with propolis and turmeric and the value of the variable at the end of placebo administration. Statistical analyzes will be performed using SPSS version 22.0.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a longitudinal randomized, double-blind, placebo-controlled clinical trial with patients with CKD undergoing hemodialysis. Patients will be randomized and divided into two groups: intervention group, which will receive microcapsules containing 250mg of propolis and 250mg of turmeric, twice a day, for 12 weeks, and placebo group, which will receive for the same amount of capsules containing arabic gum and cornstarch.
| Arm | Type | Receives |
|---|---|---|
| Microcapsules with turmeric and propolis | Active comparator | Dietary Supplement: Microcapsules with turmeric and propolisParticipants will receive microcapsules containing 0.250 milligrams of turmeric 95% curcumin and 0.250 milligrams of green propolis |
| Placebo Group | Placebo comparator | Dietary Supplement: Microcapsules with turmeric and propolisParticipants will receive microcapsules containing arabic gum and cornstarch with the same weight and characteristics as the intersecting microcapsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with stage 5 CKD (GFR < 15 mL/min);
- On hemodialysis for more than 6 months;
- Who have arteriovenous fistula (AVF) as vascular access
Key exclusion criteria (6 listed)
- Pregnant women;
- Smokers;
- Using antibiotics in the last 3 months;
- Using antioxidant supplements;
- Who have habitual intake of propolis, curcumin and turmeric;
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 |
|---|---|---|
| Microcapsules with turmeric and propolisParticipants will receive microcapsules containing 0.250 milligrams of turmeric 95% curcumin and 0.250 milligrams of green propolis, twice a day for 12 weeks | Dietary supplement | Microcapsules with turmeric and propolis, Placebo Group |
Primary outcome
The effects of the supplementation on the expression of transcription factors
Time frame: 4 months
Obtain blood samples to assess the effects of supplementation on biomarkers related to inflammation and antioxidant capacity, such as: erythroid nuclear transcription factor 2 (Nrf2) and nuclear factor Kappa B (NF-κB)
The effects of the supplementation on inflammatory cytokines
Time frame: 4 months
Get blood samples to evaluate the supplementation effects on cytokines (IL-6, TNF-α)
1 secondary outcome
The effects of supplementation on CRP levels
Time frame: 4 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 3 Apr 2025.
- Derived from this study: PubMed 40296308Nascimento D, Britto I, Couto H, Alvarenga L, Cardozo LFMF, Berretta AA, Ribeiro-Alves M, da Cunha DF, de Almeida CORP, Lemos I, Guerra MMG, Costa MES, Nakao LS, Teodoro AJ, Mafra D. Effects of a Functional Food Mixture on Patients Undergoing Hemodialysis: Preliminary Results Highlighting the Modulation of Uremic Toxins Derived From Microbiota and Antioxidant Markers. Mol Nutr Food Res. 2025 Jul;69(14):e70083. doi: 10.1002/mnfr.70083. Epub 2025 Apr 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Denise Mafra, phd principal investigator
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 Microcapsules with turmeric and propolis in people with Chronic Kidney Diseases and Inflammation, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of the supplementation on the expression of transcription factors (time frame: 4 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?
On the ClinicalTrials.gov record for NCT05183737, which also lists 1 linked publication.
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 3 Apr 2025.