Effects of Gum Arabic Supplementation in Hemodialysis Patients

University of Khartoum

Status: Unknown

Conditions: Kidney Failure, Chronic

Treatments: Other: Placebo; Dietary Supplement: Gum Arabic

Study type: Interventional

Funder types: Other

Identifiers

NCT03789708

016227

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Gum Arabic

B

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

C

Experimental group

Description:

Patients will receive 20 g of Gum Arabic supplementation daily for four weeks

Treatment:

Dietary Supplement: Gum Arabic

D

Experimental group

Description:

Patients will receive 40 g of Gum Arabic supplementation daily for four weeks

Treatment:

Dietary Supplement: Gum Arabic