Effects of Brazil Nut Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease Undergoing Conservative Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 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 aim of this study is to evaluate the effects of Brazil nut supplementation on inflammation, oxidative stress and intestinal microbiota in patients with chronic kidney disease undergoing conservative treatment.
详细描述
Complications such as inflammation and oxidative stress are common in chronic kidney disease (CKD) and directly influence the rate of disease progression. Patients with CKD also have intestinal dysbiosis, which aggravates the inflammatory process and oxidative stress, forming a vicious circle between inflammation, oxidative stress and intestinal dysbiosis. Nutritional strategies try to alleviate this circle and Brazil nuts, rich in bioactive compounds, have already been proven effective in mitigating inflammation and oxidative stress in CKD patients on dialysis. However, to date, the effectiveness of Brazil nuts in patients with CKD in stages prior to dialysis (conservative treatment) has not been tested. The bioactive compounds in Brazil nuts are expected to contribute positively to the redox balance, reduction of inflammation and intestinal eubiosis in patients with CKD undergoing conservative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with more than three months of nutritional monitoring at the Renal Nutrition Outpatient Clinic of the Universidade Federal Fluminense (UFF), between stages G3a and G4, will be included, according to KDOQI 2020 guidelines, and authorized by the medical and nutritionist team.
排除标准
- •Current use or in the last three months of antibiotics, anti-inflammatories and/or antioxidant supplements. Patients who are allergic, intolerant, or regularly ingest Brazil nuts; pregnant/lactating women, smokers; undergoing cancer treatment, HIV-positive, or with any clinical condition that compromises the accuracy of the intervention.
研究组 & 干预措施
Washout
Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided.
Crossover
the crossover between the groups will allow the same participant to be exposed, at different times, to the intervention stage and the control stage.
Brazil nut
Each patient will receive 30 units of Brazil nuts per month, to consume one nut/day for two months. The time and daily amount of nuts were based on the European Food Safety recommendation Authority (EFSA). The adequate value for selenium intake was determined by EFSA aiming at the maximum serum concentration of Selenoprotein P and glutathione peroxidase activity, reached between four and 10 weeks, with 70 µg/day; we consider that a Brazil nut can contain up to 400 µg of Se.
The use of fresh nuts made it impossible to use a placebo with the same sensory characteristics. Then, in the control stage, volunteers will receive conventional conservative nutritional treatment, without nut supplementation.
干预措施: Brazil Nut (Dietary Supplement)
结局指标
主要结局
Change in antioxidants and anti-inflammatory biomarkers
时间窗: 8 weeks
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
- Change in microbiota composition(8 weeks)
- Change in inflammatory biomarkers(8 weeks)