Chocolate for Patients With Chronic Kidney Disease

Universidade Federal Fluminense

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Dark Chocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT04600258

DeniseMafra10

Details and patient eligibility

About

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.

Full 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).

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups

Chocolate Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dark Chocolate

Control Group

No Intervention group

Description:

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