Chocolate for Patients With Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Dark Chocolate

• Registration Number: NCT04600258
• Lead Sponsor: Universidade Federal Fluminense

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).

Study Timeline

• Study First Submitted: 2020-10-18
• Study First Submitted QC: 2020-10-18
• Study First Posted: 2020-10-23
• Study Start: 2020-10-30
• Primary Completion: 2021-04-01
• Study Completion: 2021-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chocolate Group	Dark Chocolate	Administration of 40g dark chocolate per day, for 2 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Uremic toxins	2 months	Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de Janeiro, RJ, Brazil