Chronic Kidney Disease
Conditions
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).
Interventions
DIETARY_SUPPLEMENTDark Chocolate
The patients will receive 40g per day of dark chocolate for 2 months
Sponsors
Universidade Federal Fluminense
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention model description
Chocolate group Control Group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidants and anti-inflammatory biomarkers | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uremic toxins | 2 months | Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels |
Countries
Brazil
Outcome results
None listed