NCT04600258

Brief 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. This study will evaluate the potential salutogenic contribution of chocolate intake, to mitigate inflammatory and oxidative burden in chronic kidney disease patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

October 18, 2020

Last Update Submit

March 20, 2024

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    2 months

Secondary Outcomes (1)

  • Uremic toxins

    2 months

Study Arms (2)

Chocolate Group

EXPERIMENTAL

Administration of 40g dark chocolate per day, for 2 months

Dietary Supplement: Dark Chocolate

Control Group

NO INTERVENTION

No intervention and analysis will be performed before and after 2 months

Interventions

Dark ChocolateDIETARY_SUPPLEMENT

The patients will receive 40g per day of dark chocolate for 2 months

Chocolate Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Chronic Kidney Disease
  • Hemodialysis patients for more than 6 months
  • Aged 18 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260-050, Brazil

Location

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

Related Publications (4)

  • 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: 32718711BACKGROUND

  • 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: 40020766DERIVED

  • 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: 39562414DERIVED

  • 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.

    PMID: 36657913DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Chocolate group Control Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 23, 2020

Study Start

October 30, 2020

Primary Completion

April 1, 2021

Study Completion

December 1, 2021

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)