Chronic Kidney DiseaseNCT04600258
Chocolate for Patients With Chronic Kidney Disease
A study testing Dark Chocolate in people with Chronic Kidney Disease, run by Universidade Federal Fluminense at 2 sites in Brazil.
Trial summary
Chocolate is a widely appreciated foodstuff with historical appreciation as food from the gods. It is a rich source of (poly)phenolics, which have several proposed salutogenic effects, including neuroprotective anti-inflammatory, antioxidant, and cardioprotective properties. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Dark Chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Oct 2020to 1 Dec 2021
- 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
- Clinical diagnosis of Chronic Kidney Disease
- Hemodialysis patients for more than 6 months
- Aged 18 years or older
Who cannot join
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- Clinical diagnosis of infectious diseases
- Clinical diagnosis of Cancer
- Clinical diagnosis of AIDS
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260-050
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050
About this study
Official title: Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?
Chocolate is a widely appreciated foodstuff with historical appreciation as food from the gods. It is a rich source of (poly)phenolics, which have several proposed salutogenic effects, including neuroprotective anti-inflammatory, antioxidant, and cardioprotective properties.
This study will evaluate the potential salutogenic contribution of chocolate intake, to mitigate inflammatory and oxidative burden in chronic kidney disease patients.
Read the detailed description
This study is evaluating patients with CKD on a regular HD program randomized in the chocolate group and control group. The chocolate group is receiving 40g of dark chocolate per day for 2 months and the control group is not receiving any intervention. Peripheral blood mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone oxidoreductase 1 (NQO1) by a quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Chronic Kidney Disease
- Being tested
- Dark Chocolate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark ChocolateDietary supplement
The patients will receive 40g per day of dark chocolate for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Chocolate Group | Experimental | Administration of 40g dark chocolate per day, for 2 months Receives: Dietary Supplement: Dark Chocolate |
| Control Group | No intervention | No intervention and analysis will be performed before and after 2 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidants and anti-inflammatory biomarkers
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
Measured: 2 months
Inflammatory biomarkers
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)
Measured: 2 months
Secondary outcomes (1)
Uremic toxins
Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start30 Oct 2020
- Primary completion1 Apr 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Chocolate group Control Group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Mafra, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600258
- Sponsor's protocol ID
- DeniseMafra10
- Status last verified
- Mar 2024
- First submitted
- 18 Oct 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanton S, Cardozo LFMF, Combet E, Shiels PG, Stenvinkel P, Vieira IO, Narciso HR, Schmitz J, Mafra D. The sweet side of dark chocolate for chronic kidney disease patients. Clin Nutr. 2021 Jan;40(1):15-26. doi: 10.1016/j.clnu.2020.06.039. Epub 2020 Jul 14.
PubMed 32718711Kemp JA, Fanton S, Baptista BG, Ribeiro M, Cardozo LFMF, Ribeiro-Alves M, Mafra D. Short Report: Influence of Dark Chocolate Intake on Magnesium Status in Hemodialysis Patients. J Ren Nutr. 2025 Jul;35(4):545-549. doi: 10.1053/j.jrn.2025.02.002. Epub 2025 Feb 26.
PubMed 40020766Kemp JA, Schultz J, Modolon F, Ribeiro-Alves M, Rosado AS, Mafra D. Is there a correlation between TMAO plasma levels and archaea in the gut of patients undergoing hemodialysis? Int Urol Nephrol. 2025 Apr;57(4):1269-1275. doi: 10.1007/s11255-024-04273-5. Epub 2024 Nov 19.
PubMed 39562414Ribeiro M, Fanton S, Paiva BR, Baptista BG, Alvarenga L, Ribeiro-Alves M, Cardozo LF, Mafra D. Dark chocolate (70% cocoa) attenuates the inflammatory marker TNF-alpha in patients on hemodialysis. Clin Nutr ESPEN. 2023 Feb;53:189-195. doi: 10.1016/j.clnesp.2022.12.009. Epub 2022 Dec 9.
PubMed 36657913
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?
- ClinicalTrials.gov ID
- NCT04600258
- Acronym / sponsor ID
- DeniseMafra10
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 23 Oct 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.
Chocolate is a widely appreciated foodstuff with historical appreciation as food from the gods. It is a rich source of (poly)phenolics, which have several proposed salutogenic effects, including neuroprotective anti-inflammatory, antioxidant, and cardioprotective properties.
This study will evaluate the potential salutogenic contribution of chocolate intake, to mitigate inflammatory and oxidative burden in chronic kidney disease patients.
Detailed description
This study is evaluating patients with CKD on a regular HD program randomized in the chocolate group and control group. The chocolate group is receiving 40g of dark chocolate per day for 2 months and the control group is not receiving any intervention. Peripheral blood mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone oxidoreductase 1 (NQO1) by a quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Chocolate group Control Group
| Arm | Type | Receives |
|---|---|---|
| Chocolate Group | Experimental | Dietary Supplement: Dark ChocolateAdministration of 40g dark chocolate per day, for 2 months |
| Control Group | No intervention | –No intervention and analysis will be performed before and after 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Chronic Kidney Disease
- Hemodialysis patients for more than 6 months
- Aged 18 years or older
Key exclusion criteria (7 listed)
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- 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 |
|---|---|---|
| Dark ChocolateThe patients will receive 40g per day of dark chocolate for 2 months | Dietary supplement | Chocolate Group |
Primary outcome
Antioxidants and anti-inflammatory biomarkers
Time frame: 2 months
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
Inflammatory biomarkers
Time frame: 2 months
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)
1 secondary outcome
Uremic toxins
Time frame: 2 months
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 22 Mar 2024.
- Background: PubMed 32718711Fanton S, Cardozo LFMF, Combet E, Shiels PG, Stenvinkel P, Vieira IO, Narciso HR, Schmitz J, Mafra D. The sweet side of dark chocolate for chronic kidney disease patients. Clin Nutr. 2021 Jan;40(1):15-26. doi: 10.1016/j.clnu.2020.06.039. Epub 2020 Jul 14.
- Derived from this study: PubMed 40020766Kemp JA, Fanton S, Baptista BG, Ribeiro M, Cardozo LFMF, Ribeiro-Alves M, Mafra D. Short Report: Influence of Dark Chocolate Intake on Magnesium Status in Hemodialysis Patients. J Ren Nutr. 2025 Jul;35(4):545-549. doi: 10.1053/j.jrn.2025.02.002. Epub 2025 Feb 26.
- Derived from this study: PubMed 39562414Kemp JA, Schultz J, Modolon F, Ribeiro-Alves M, Rosado AS, Mafra D. Is there a correlation between TMAO plasma levels and archaea in the gut of patients undergoing hemodialysis? Int Urol Nephrol. 2025 Apr;57(4):1269-1275. doi: 10.1007/s11255-024-04273-5. Epub 2024 Nov 19.
- Derived from this study: PubMed 36657913Ribeiro M, Fanton S, Paiva BR, Baptista BG, Alvarenga L, Ribeiro-Alves M, Cardozo LF, Mafra D. Dark chocolate (70% cocoa) attenuates the inflammatory marker TNF-alpha in patients on hemodialysis. Clin Nutr ESPEN. 2023 Feb;53:189-195. doi: 10.1016/j.clnesp.2022.12.009. Epub 2022 Dec 9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark Chocolate in people with Chronic Kidney Disease, 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 3 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 22 Mar 2024. 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. 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?
Antioxidants and anti-inflammatory biomarkers (time frame: 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?
On the ClinicalTrials.gov record for NCT04600258, which also lists 4 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 22 Mar 2024.