Effects of Gum Arabic Supplementation in Hemodialysis Patients

Not Applicable

• Conditions: Kidney Failure, Chronic
• Interventions: Dietary Supplement: Gum Arabic; Other: Placebo

• Registration Number: NCT03789708
• Lead Sponsor: University of Khartoum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-31
• Last Update Submitted: 2018-12-31
• Last Update Posted: 2019-01-03
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Gum Arabic	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.
C	Gum Arabic	Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
D	Gum Arabic	Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
B	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Highly sensitive C-reactive protein (hs CRP) level	4 weeks	Change in serum level of highly sensitive C-reactive protein.
Total anti-oxidant capacity	4 weeks	Change in serum total anti-oxidant capacity
Blood urea level	4 weeks	Change in urea blood level

Secondary Outcome Measures

Name	Time	Method
Serum uric acid	4 weeks	Change in serum uric acid level
Serum calcium	4 weeks	Change in serum calcium level
Serum phosphorus	4 weeks	Change in serum phosphorus level

Trial Locations

Locations (1)

Doctor Salma Center for Kidney Diseases; 🇸🇩 Khartoum, Sudan