Effects of Gum Arabic Supplementation in Hemodialysis Patients
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贊助商
University of Khartoum
合作者
National Center for Kidney Diseases and Surgery
Almughtaribeen University
臨床試驗: NCT03789708
BioSeek: NCT03789708
關鍵詞
抽象
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.
日期
| 最後驗證: | 11/30/2018 |
| 首次提交: | 12/26/2018 |
| 提交的預估入學人數: | 12/26/2018 |
| 首次發布: | 12/30/2018 |
| 上次提交的更新: | 12/30/2018 |
| 最近更新發布: | 01/02/2019 |
| 實際學習開始日期: | 10/31/2018 |
| 預計主要完成日期: | 02/28/2019 |
| 預計完成日期: | 05/31/2019 |
狀況或疾病
Kidney Failure, Chronic
干預/治療
Dietary Supplement: Gum Arabic
Other: B
相
-
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: 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. | |
| Placebo Comparator: 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. | Other: B Maltodextrin powder, easily soluble |
| Experimental: C Patients will receive 20 g of Gum Arabic supplementation daily for four weeks | |
| Experimental: D Patients will receive 40 g of Gum Arabic supplementation daily for four weeks |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: - Adult end-stage renal disease patients maintained on regular hemodialysis Exclusion Criteria: - Chronic liver disease - Malignant condition - Inflammatory bowel disease - History of bowel resection - Long term antibiotic therapy - Pregnancy or lactation - Current use of immunosuppressive medication |
結果
主要結果指標
1. Highly sensitive C-reactive protein (hs CRP) level [4 weeks]
Change in serum level of highly sensitive C-reactive protein.
2. Total anti-oxidant capacity [4 weeks]
Change in serum total anti-oxidant capacity
3. Blood urea level [4 weeks]
Change in urea blood level
次要成果指標
1. Serum calcium [4 weeks]
Change in serum calcium level
2. Serum phosphorus [4 weeks]
Change in serum phosphorus level
3. Serum uric acid [4 weeks]
Change in serum uric acid level
