Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in antioxidants and anti-inflammatory biomarkers
研究概览
简要总结
The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.
详细描述
In Chronic Kidney Disease (CKD), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. Currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. In this regard, strategies in the management of this framework are necessary. It has been observed that vitamin E plays an important role in the modulation of transcription factors involved in inflammation such as NF-kB and Nrf2, acting on cell membrane protection and tissue recovery. Its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin E supplementation in the modulation of intestinal microbiota with consequent effect on CKD and its reflexes are scarce. Thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin E supplementation on the modulation of the expression of nuclear cytokine (NF-kB e Nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, 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
- •Chronic kidney disease
- •Aged from 18 to 60 years
- •Must be able to swallow capsules
排除标准
- •Pregnant patients
- •Using antibiotics in the last 3 months
- •Using antioxidant supplements in the last 3 months
- •Usual intake Autoimmune
- •Hemodialysis started less than 6 months for hemodialysis patients
研究组 & 干预措施
Effects of supplementation with tocotrienol on chronic kidney disease patients
Administration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months.
干预措施: Tocotrienol rich fraction (Dietary Supplement)
Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients
Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in antioxidants and anti-inflammatory biomarkers
时间窗: 4 weeks
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1). glutathione peroxidase (GPx), heme oxygenase-1 (HO-1) and microbiota composition from patients feces DNA uremic toxins
次要结局
- Change in inflammatory biomarkers(4 weeks)
