Chocolate for Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dark Chocolate
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Chronic Kidney Disease
- Hemodialysis patients for more than 6 months
- Aged 18 years or older
Exclusion Criteria:
- 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
Sites / Locations
- Denise Mafra
- Denise Mafra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chocolate Group
Control Group
Arm Description
Administration of 40g dark chocolate per day, for 2 months
No intervention and analysis will be performed before and after 2 months
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Uremic toxins
Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels
Full Information
NCT ID
NCT04600258
First Posted
October 18, 2020
Last Updated
September 26, 2022
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT04600258
Brief Title
Chocolate for Patients With Chronic Kidney Disease
Official Title
Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Chocolate group Control Group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chocolate Group
Arm Type
Experimental
Arm Description
Administration of 40g dark chocolate per day, for 2 months
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention and analysis will be performed before and after 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Dark Chocolate
Intervention Description
The patients will receive 40g per day of dark chocolate for 2 months
Primary Outcome Measure Information:
Title
Antioxidants and anti-inflammatory biomarkers
Description
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
Time Frame
2 months
Title
Inflammatory biomarkers
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)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Uremic toxins
Description
Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Chronic Kidney Disease
Hemodialysis patients for more than 6 months
Aged 18 years or older
Exclusion Criteria:
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
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260-050
Country
Brazil
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260050
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32718711
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.
Results Reference
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Learn more about this trial
Chocolate for Patients With Chronic Kidney Disease
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