Chronic Kidney DiseasesNCT04411758
Propolis for Patients With Chronic Kidney Disease.
A study testing Propolis in people with Chronic Kidney Diseases and Inflammation, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
To evaluate the effects of propolis extract on inflammation in participants with chronic kidney disease. Specific objectives To assess before and after the intervention period: The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases, Inflammation
- What is being tested?
- Propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- with fistula arteriovenous
Who cannot join
- Patients pregnant
- Smokers
- Using antibiotics in the last three months
- Using antioxidant supplements as antioxidant vitamins, probiotic, prebiotic, symbiotic and antibiotics in the last three months
- Clinical diagnosis of infectious diseases
- Clinical diagnosis of Cancer
- Clinical diagnosis of AIDS - for PD patients - no peritonitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propolis as a New Strategy in Modulating Inflammation in Patients With Chronic Kidney Disease.
To evaluate the effects of propolis extract on inflammation in participants with chronic kidney disease.
Specific objectives
Read more
To assess before and after the intervention period:
- The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome proliferator-activated receptor-γ, as well as the levels of inflammatory cytokines (IL-6, Tumor nuclear factor-α, C-reactive protein, interleukin 1) and E-selectin adhesion molecules;
- The levels of protein expression of inflammatory markers and antioxidant enzymes;
- The profile of the intestinal microbiota of stool samples from the research participants;
- Plasma levels of substances reactive to thiobarbituric acid and oxidized low density lipoprotein as a marker of oxidative stress;
- Routine and anthropometric laboratory variables, indicative of the metabolic profile of the research participants;
- Assess blood pressure, 6-minute walk test, recovery heart rate and chair lift test to assess the functional capacity of the research participants;
- Assess atherogenic risk;
- Food intake and nutritional status; Compare data between the intervention and control groups.
Read the detailed description
Chronic kidney disease (CKD) has chronic systemic inflammation as an important component of multifactorial origin, a factor related to both the progression and outcomes of CKD, being involved in all causes of mortality in these patients, such as cardiovascular disease. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation, starting from the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation and oxidative stress, factors that feed on each other. In view of this scenario, propolis, a substance made up of a combination of several chemical components with broad potential biological activity, appears as a promising alternative to modulate inflammation in patients with CKD. However, clinical evidence to assess the effects of propolis in patients with CKD is scarce, and there are no studies that have investigated its effects on gene expression and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of propolis alcoholic extract on transcription factors and inflammatory markers in patients with CKD.
- Conditions
- Chronic Kidney Diseases, Inflammation
- Being tested
- Propolis, Placebo
- Keywords
- chronic kidney disease, non-dialysis, propolis, inflammation
- 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.
PropolisDietary supplement
Four capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months and after washout, more two months crossover
PlaceboDietary supplement
Four capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months and after washout, more two months crossover
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Patients will receive 4 capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months Receives: Dietary Supplement: Placebo |
| Propolis Group | Experimental | Patients will receive 4 capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months Receives: Dietary Supplement: Propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokines plasma levels measured by ELISA after supplementation with propolis.
IL-6, Tumor necrosis factor (TNF)
Measured: 4 months
Change the expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome, peroxisome proliferator-activated receptor-γ
nuclear factor (NF)-kappa B
Measured: 4 months
Change the profile of the intestinal microbiota of stool samples
uremic toxins
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 posted2 Jun 2020
- Study start12 Jan 2021
- Primary completion29 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Crossover
- Model description
- In this clinical trial, participants with CKD undergoing hemodialysis or peritoneal dialysis will be instructed to use 4 capsules of 500mg/day containing concentrated and standardized dry green propolis extract (EPP-AF®) for 2 months or placebo (4 capsules of 500mg/day of magnesium stearate, silicon dioxide and microcrystalline cellulose) for two months, and then the groups will be crossed and will receive the same amount of propolis as the first group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
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
- NCT04411758
- Sponsor's protocol ID
- Denise Mafra8
- Status last verified
- Feb 2024
- First submitted
- 28 May 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fonseca L, Ribeiro M, Schultz J, Borges NA, Cardozo L, Leal VO, Ribeiro-Alves M, Paiva BR, Leite PEC, Sanz CL, Kussi F, Nakao LS, Rosado A, Stenvinkel P, Mafra D. Effects of Propolis Supplementation on Gut Microbiota and Uremic Toxin Profiles of Patients Undergoing Hemodialysis. Toxins (Basel). 2024 Sep 25;16(10):416. doi: 10.3390/toxins16100416.
PubMed 39453192Baptista BG, Fanton S, Ribeiro M, Cardozo LF, Regis B, Alvarenga L, Ribeiro-Alves M, Berretta AA, Shiels PG, Mafra D. The effect of Brazilian Green Propolis extract on inflammation in patients with chronic kidney disease on peritoneal dialysis: A randomised double-blind controlled clinical trial. Phytomedicine. 2023 Jun;114:154731. doi: 10.1016/j.phymed.2023.154731. Epub 2023 Mar 1.
PubMed 36934668Chermut TR, Fonseca L, Figueiredo N, de Oliveira Leal V, Borges NA, Cardozo LF, Correa Leite PE, Alvarenga L, Regis B, Delgado A, Berretta AA, Ribeiro-Alves M, Mafra D. Effects of propolis on inflammation markers in patients undergoing hemodialysis: A randomized, double-blind controlled clinical trial. Complement Ther Clin Pract. 2023 May;51:101732. doi: 10.1016/j.ctcp.2023.101732. Epub 2023 Jan 26.
PubMed 36708650
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis as a New Strategy in Modulating Inflammation in Patients With Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT04411758
- Acronym / sponsor ID
- Denise Mafra8
- Conditions
- Chronic Kidney Diseases, Inflammation
- Keywords
- chronic kidney disease, non-dialysis, propolis, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Jun 2020 (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.
To evaluate the effects of propolis extract on inflammation in participants with chronic kidney disease.
Specific objectives
To assess before and after the intervention period:
- The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome proliferator-activated receptor-γ, as well as the levels of inflammatory cytokines (IL-6, Tumor nuclear factor-α, C-reactive protein, interleukin 1) and E-selectin adhesion molecules;
- The levels of protein expression of inflammatory markers and antioxidant enzymes;
- The profile of the intestinal microbiota of stool samples from the research participants;
- Plasma levels of substances reactive to thiobarbituric acid and oxidized low density lipoprotein as a marker of oxidative stress;
- Routine and anthropometric laboratory variables, indicative of the metabolic profile of the research participants;
- Assess blood pressure, 6-minute walk test, recovery heart rate and chair lift test to assess the functional capacity of the research participants;
- Assess atherogenic risk;
- Food intake and nutritional status; Compare data between the intervention and control groups.
Detailed description
Chronic kidney disease (CKD) has chronic systemic inflammation as an important component of multifactorial origin, a factor related to both the progression and outcomes of CKD, being involved in all causes of mortality in these patients, such as cardiovascular disease. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation, starting from the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation and oxidative stress, factors that feed on each other. In view of this scenario, propolis, a substance made up of a combination of several chemical components with broad potential biological activity, appears as a promising alternative to modulate inflammation in patients with CKD. However, clinical evidence to assess the effects of propolis in patients with CKD is scarce, and there are no studies that have investigated its effects on gene expression and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of propolis alcoholic extract on transcription factors and inflammatory markers in patients with CKD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this clinical trial, participants with CKD undergoing hemodialysis or peritoneal dialysis will be instructed to use 4 capsules of 500mg/day containing concentrated and standardized dry green propolis extract (EPP-AF®) for 2 months or placebo (4 capsules of 500mg/day of magnesium stearate, silicon dioxide and microcrystalline cellulose) for two months, and then the groups will be crossed and will receive the same amount of propolis as the first group.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboPatients will receive 4 capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months |
| Propolis Group | Experimental | Dietary Supplement: PropolisPatients will receive 4 capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or older
- with fistula arteriovenous
Key exclusion criteria (7 listed)
- Patients pregnant
- Smokers
- Using antibiotics in the last three months
- Using antioxidant supplements as antioxidant vitamins, probiotic, prebiotic, symbiotic and antibiotics in the last three months
- Clinical diagnosis of 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 |
|---|---|---|
| PropolisFour capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months and after washout, more two months crossover | Dietary supplement | Propolis Group |
| PlaceboFour capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months and after washout, more two months crossover | Dietary supplement | Placebo Group |
Primary outcome
Change in cytokines plasma levels measured by ELISA after supplementation with propolis.
Time frame: 4 months
IL-6, Tumor necrosis factor (TNF)
Change the expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome, peroxisome proliferator-activated receptor-γ
Time frame: 4 months
nuclear factor (NF)-kappa B
Change the profile of the intestinal microbiota of stool samples
Time frame: 4 months
uremic toxins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 39453192Fonseca L, Ribeiro M, Schultz J, Borges NA, Cardozo L, Leal VO, Ribeiro-Alves M, Paiva BR, Leite PEC, Sanz CL, Kussi F, Nakao LS, Rosado A, Stenvinkel P, Mafra D. Effects of Propolis Supplementation on Gut Microbiota and Uremic Toxin Profiles of Patients Undergoing Hemodialysis. Toxins (Basel). 2024 Sep 25;16(10):416. doi: 10.3390/toxins16100416.
- Derived from this study: PubMed 36934668Baptista BG, Fanton S, Ribeiro M, Cardozo LF, Regis B, Alvarenga L, Ribeiro-Alves M, Berretta AA, Shiels PG, Mafra D. The effect of Brazilian Green Propolis extract on inflammation in patients with chronic kidney disease on peritoneal dialysis: A randomised double-blind controlled clinical trial. Phytomedicine. 2023 Jun;114:154731. doi: 10.1016/j.phymed.2023.154731. Epub 2023 Mar 1.
- Derived from this study: PubMed 36708650Chermut TR, Fonseca L, Figueiredo N, de Oliveira Leal V, Borges NA, Cardozo LF, Correa Leite PE, Alvarenga L, Regis B, Delgado A, Berretta AA, Ribeiro-Alves M, Mafra D. Effects of propolis on inflammation markers in patients undergoing hemodialysis: A randomized, double-blind controlled clinical trial. Complement Ther Clin Pract. 2023 May;51:101732. doi: 10.1016/j.ctcp.2023.101732. Epub 2023 Jan 26.
- 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 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 26 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cytokines plasma levels measured by ELISA after supplementation with propolis. (time frame: 4 months). The study lists 3 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 NCT04411758, which also lists 3 linked publications.
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 26 Feb 2024.