Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Inflammatory biomarkers
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Chronic Kidney Disease
- •Hemodialysis patients for more than 6 months
- •Aged 18 years or older
排除标准
- •Patients pregnant
- •Using antibiotics in the last 3 months
- •Autoimmune diseases
- •Clinical diagnosis of infectious diseases
- •Clinical diagnosis of Cancer
- •Clinical diagnosis of AIDS
研究组 & 干预措施
Control Group
No intervention and analysis will be performed before and after 2 months
结局指标
主要结局
Inflammatory biomarkers
时间窗: 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)
Antioxidants and anti-inflammatory biomarkers
时间窗: 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)
次要结局
- Uremic toxins(2 months)
研究者
Denise Mafra
Full Professor
Universidade Federal Fluminense