Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Khartoum
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Highly sensitive C-reactive protein (hs CRP) level
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
The placebo and the Gum Arabic are provided to patients in similar unlabeled packages
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Placebo (Other)
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.
Intervention: Gum Arabic (Dietary Supplement)
C
Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
Intervention: Gum Arabic (Dietary Supplement)
D
Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
Intervention: Gum Arabic (Dietary Supplement)
Outcomes
Primary Outcomes
Highly sensitive C-reactive protein (hs CRP) level
Time Frame: 4 weeks
Change in serum level of highly sensitive C-reactive protein.
Total anti-oxidant capacity
Time Frame: 4 weeks
Change in serum total anti-oxidant capacity
Blood urea level
Time Frame: 4 weeks
Change in urea blood level
Secondary Outcomes
- Serum uric acid(4 weeks)
- Serum calcium(4 weeks)
- Serum phosphorus(4 weeks)
Investigators
Sarra Elamin
Assistant Professor
University of Khartoum