Chocolate for Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Dark Chocolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Chocolate group Control Group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chocolate Group<br>Administration of 40g dark chocolate per day, for 2 months | Dietary Supplement: Dark Chocolate<br>* The patients will receive 40g per day of dark chocolate for 2 months<br>|
| No Intervention: Control Group<br>No intervention and analysis will be performed before and after 2 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uremic toxins | Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels | 2 months |