Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Highly sensitive C-reactive protein (hs CRP) level
研究概览
简要总结
Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The placebo and the Gum Arabic are provided to patients in similar unlabeled packages
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult end-stage renal disease patients maintained on regular hemodialysis
排除标准
- •Chronic liver disease
- •Malignant condition
- •Inflammatory bowel disease
- •History of bowel resection
- •Long term antibiotic therapy
- •Pregnancy or lactation
- •Current use of immunosuppressive medication
研究组 & 干预措施
B
Patients will receive 5 g of maltodextrin supplementation daily for four weeks. Maltodextrin is an easily digested polysacharide provided in the form of soluble whitish powder that has no taste or odor. Participants are asked to dissolve it in water or juice and drink it.
干预措施: Placebo (Other)
D
Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
干预措施: Gum Arabic (Dietary Supplement)
C
Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
干预措施: Gum Arabic (Dietary Supplement)
A
Patients will receive 10 g of Gum Arabic supplementation daily for four weeks. Gum Arabic is provided in the form of easily soluble granules. Participants are asked to dissolve it in water or juice and drink it.
干预措施: Gum Arabic (Dietary Supplement)
结局指标
主要结局
Highly sensitive C-reactive protein (hs CRP) level
时间窗: 4 weeks
Change in serum level of highly sensitive C-reactive protein.
Total anti-oxidant capacity
时间窗: 4 weeks
Change in serum total anti-oxidant capacity
Blood urea level
时间窗: 4 weeks
Change in urea blood level
次要结局
- Serum uric acid(4 weeks)
- Serum calcium(4 weeks)
- Serum phosphorus(4 weeks)
研究者
Sarra Elamin
Assistant Professor
University of Khartoum