Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT04600258
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2020-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chocolate for Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Chocolate group Control Group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2020-10-18', 'studyFirstSubmitQcDate': '2020-10-18', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antioxidants and anti-inflammatory biomarkers', 'timeFrame': '2 months', 'description': 'Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)'}, {'measure': 'Inflammatory biomarkers', 'timeFrame': '2 months', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Uremic toxins', 'timeFrame': '2 months', 'description': 'Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '32718711', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40020766', 'type': 'DERIVED', 'citation': 'Kemp 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.'}, {'pmid': '39562414', 'type': 'DERIVED', 'citation': 'Kemp 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.'}, {'pmid': '36657913', 'type': 'DERIVED', 'citation': 'Ribeiro 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis study will evaluate the potential salutogenic contribution of chocolate intake, to mitigate inflammatory and oxidative burden in chronic kidney disease patients.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Chronic Kidney Disease\n* Hemodialysis patients for more than 6 months\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Patients pregnant\n* Smokers\n* Using antibiotics in the last 3 months\n* Autoimmune diseases\n* Clinical diagnosis of infectious diseases\n* Clinical diagnosis of Cancer\n* Clinical diagnosis of AIDS'}, 'identificationModule': {'nctId': 'NCT04600258', 'briefTitle': 'Chocolate for Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal Fluminense'}, 'officialTitle': 'Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?', 'orgStudyIdInfo': {'id': 'DeniseMafra10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chocolate Group', 'description': 'Administration of 40g dark chocolate per day, for 2 months', 'interventionNames': ['Dietary Supplement: Dark Chocolate']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No intervention and analysis will be performed before and after 2 months'}], 'interventions': [{'name': 'Dark Chocolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients will receive 40g per day of dark chocolate for 2 months', 'armGroupLabels': ['Chocolate Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22260-050', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Denise Mafra', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22260050', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Denise Mafra', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal Fluminense', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Denise Mafra', 'investigatorAffiliation': 'Universidade Federal Fluminense'}}}}