Effects of Gum Arabic Supplementation in Hemodialysis Patients

Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients

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 Overview

• Status: Unknown
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Dietary supplement: Gum Arabic; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sudan
  • Khartoum, Sudan, 11111
    • Doctor Salma Center for Kidney Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Gum Arabic; Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
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: Placebo; Maltodextrin powder, easily soluble
Experimental: C; Patients will receive 20 g of Gum Arabic supplementation daily for four weeks	Dietary supplement: Gum Arabic; Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
Experimental: D; Patients will receive 40 g of Gum Arabic supplementation daily for four weeks	Dietary supplement: Gum Arabic; Instantly soluble granules of Gum Arabic; 100% Acacia Senegal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum calcium	Change in serum calcium level	4 weeks
Serum phosphorus	Change in serum phosphorus level	4 weeks
Serum uric acid	Change in serum uric acid level	4 weeks

Collaborators and Investigators

• Sponsor: University of Khartoum
• Collaborators: National Center for Kidney Diseases and Surgery; Almughtaribeen University
• Investigators: Principal Investigator: Sarra Elamin, MD, Consultant Nephrologist

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 016227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No