Effects of Gum Arabic Supplementation in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Dietary Supplement: Gum Arabic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized and controlled clinical trial with parallel design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* Instantly soluble granules of Gum Arabic; 100% Acacia Senegal<br>|
| Placebo Comparator: B<br>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<br>* Maltodextrin powder, easily soluble<br>|
| Experimental: C<br>Patients will receive 20 g of Gum Arabic supplementation daily for four weeks | Dietary Supplement: Gum Arabic<br>* Instantly soluble granules of Gum Arabic; 100% Acacia Senegal<br>|
| Experimental: D<br>Patients will receive 40 g of Gum Arabic supplementation daily for four weeks | Dietary Supplement: Gum Arabic<br>* Instantly soluble granules of Gum Arabic; 100% Acacia Senegal<br>|

What is the study measuring?
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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 |