Effects of Gum Arabic Supplementation in Hemodialysis Patients
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StatoAttivo, non reclutamento
Sponsor
University of Khartoum
Collaboratori
National Center for Kidney Diseases and Surgery
Almughtaribeen University
TEST CLINICO: NCT03789708
BioSeek: NCT03789708
Parole chiave
Astratto
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.
Date
| Ultimo verificato: | 11/30/2018 |
| Primo inviato: | 12/26/2018 |
| Iscrizione stimata inviata: | 12/26/2018 |
| Primo pubblicato: | 12/30/2018 |
| Ultimo aggiornamento inviato: | 12/30/2018 |
| Ultimo aggiornamento pubblicato: | 01/02/2019 |
| Data di inizio effettiva dello studio: | 10/31/2018 |
| Data di completamento primaria stimata: | 02/28/2019 |
| Data stimata di completamento dello studio: | 05/31/2019 |
Condizione o malattia
Kidney Failure, Chronic
Intervento / trattamento
Dietary Supplement: Gum Arabic
Other: B
Fase
-
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| 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 |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | 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 |
Risultato
Misure di esito primarie
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
Misure di esito secondarie
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
