跳至主要内容
临床试验/NCT02706808
NCT02706808已完成不适用

Effects of Supplementation With Resistant Starch in the Profile of the Intestinal Tract and Cardiovascular Markers in Patients With Chronic Kidney Disease

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch

研究概览

简要总结

The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.

详细描述

Patients with chronic kidney disease (CKD), especially those who are on dialysis have a high prevalence of cardiovascular mortality and, among the risk factors include inflammation and oxidative stress. Recently this scenario, beyond those alterations found in these patients, it has been suggested that the balance of the intestinal flora in these patients might be a new factor of cardiovascular risk. Some treatment strategies have been studied in order to modulate the gut microbiota as the use of pre, pro or synbiotics. Although few studies, supplementation with prebiotics has been recommended. However, the use of resistant starch as a source of prebiotic for modulation of the intestinal flora in these patients has not yet been evaluated, but the study of Prof. Vaziri the University of California Irvine, USA, with nephrectomized rats showed that the resistant starch was able to attenuating the progression of failure of renal function, inflammation and oxidative stress and minimize the abnormalities of intestinal epithelial barrier. The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemodialysis patients with arteriovenous fistula as vascular access in the upper limb and on maintenance dialysis for at least 6 months;
  • Patients under conservative treatment in stages 3a and 3b (30 to 60 mL / min) of chronic kidney disease and receiving nutritional treatment for at least 6 months (adequate supply of energy 30-35kcal/kg/day and hypoproteic 0.6 g/kg/day.

排除标准

  • Patients with autoimmune and infectious diseases, diabetes, cancer and AIDS;
  • Patients with catheter for hemodialysis access;
  • Patients using catabolizing drugs, supplements as antioxidant vitamin, probiotics, prebiotics, synbiotics and antibiotics.
  • Patients who exercise are also deleted.

结局指标

主要结局

Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch

时间窗: Change from Baseline inflammation at 6 weeks

after 6 weeks with resistance starch the chronic kidney disease patients should have the cytokines levels reduced

Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment

时间窗: Change from Baseline microbiota gut at 6 weeks

after 6 weeks with resistance starch the chronic kidney disease patients should have the gut microbiota modulated

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denise Mafra

Professor

Universidade Federal Fluminense

研究点 (2)

Loading locations...

相似试验

Resistant Starch Supplementation Effects on the... | 临床试验