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临床试验/NCT04900532
NCT04900532已完成不适用

Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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