Chocolate for Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600258
• Other study ID #: DeniseMafra10
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2024
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Dark Chocolate
The patients will receive 40g per day of dark chocolate for 2 months

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro	RJ
Brazil	Denise Mafra	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Uremic toxins	Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels	2 months