A Phase 1/2 interventional study of Gum Arabic and Water in End Stage Renal Disease (ESRD), sponsored by Abu Dhabi Health Services Company. Recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Abu Dhabi Health Services Company · Phase 1/2, Interventional, and Treatment
Gum Arabic (GA), derived from Acacia trees, has shown potential benefits in metabolic, renal, and inflammatory conditions. This study explores the impact of GA on residual renal function in end-stage renal disease (ESRD) patients undergoing dialysis, as current evidence is limited.
Gum Arabic (GA) is an exudate with a gummy texture obtained from Acacia seyal and Acacia senegal. It is an arabinogalactan-protein complex and is composed of magnesium, calcium, and potassium salts of Arabic acid. GA is widely used in sub-Saharan African countries as a traditional remedy for many years. Ingestion of GA has been claimed to have beneficial effects in several health conditions like metabolic syndrome, renal failure, hypertension, gingivitis, anaemia, and hypercholesterolemia. Clinical trials conducted earlier have studied the effect of GA on metabolic disorders like type 2 diabetes mellitus, hyperlipidaemia, gastrointestinal health, oral health, renal diseases, and diseases like sickle cell anaemia and rheumatoid arthritis. A few studies have described GA to exhibit antioxidant properties, anti-inflammatory, probiotic, and antibacterial properties. GA has high fibre content causing satiety and is suggested as a good dietary fibre in patients with chronic kidney disease (CKD) based on its effect on various physiological and biochemical parameters.
The effect of GA on CKD patients has only been studied in a few publications. A study of patients undergoing regular haemodialysis showed supplementation of GA 50g/day along with low protein diet for 3 months resulted in a significant reduction in serum urea, creatinine, uric acid and phosphate levels and a significant increase in serum calcium levels. Another clinical trial conducted in Saudi Arabia among CKD patients showed that supplementing the diet with GA for four weeks significantly reduced C-reactive protein (CRP) levels however, four weeks supplementation did not show any effect on the serum urea and creatinine levels. Another study on forty ESRD patients on haemodialysis showed that GA supplementation of 30g/day for 12 weeks significantly improved Hb levels and augmented total antioxidant capacity whilst reducing CRP. A clinical trial conducted on patients with stage 2 or 3 CKD demonstrated that GA supplementation of 25g/day for a year was well tolerated and was associated with a slowing in the rate of decline of renal function as measured by eGFR. A single case study published in 2009 reported the postponement of dialysis for six years in a young girl with advanced CKD using GA 1-1.5 g/kg/day combined with traditional conservative (dietary and pharmacological) treatments . A systematic review on efficacy and safety of GA in patients with CKD suggested that GA supplementation may improve parameters like serum creatinine, urea, sodium, and potassium, but early-stage intervention and long duration of therapy were more likely to improve renal parameters.
GA is commonly used in the making of food products like puddings, frostings and candies . It has demulcent property for which it is used in medications and is generally recognized as safe by the US Food and Drug Administration. Earlier animal studies in toxicology have shown that there were no significant harmful effects observed on chronic intake of GA and no known teratogenic effects in animals .
There is a paucity of data on drug interactions, but studies have shown that concurrent use of oral GA and amoxicillin changed the pharmacokinetics resulting in a significant reduction in the absorption of amoxicillin leading to sub therapeutic plasma concentrations. A animal study on gastric ulcers demonstrated that GA administration potentiated the anti-ulcer effect of ranitidine.
Limited evidence supports the beneficial effects of oral GA on renal function, and there are no definitive studies demonstrating an improvement in residual renal function in ESRD patients undergoing haemodialysis.
This trial aims to assess the effect of GA on residual renal function in ESRD patients on dialysis.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 40 is below the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Abu Dhabi Health Services Company is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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To be eligible to participate in this trial, an individual must meet all the following criteria:
Exclusion Criteria:
Additional exclusion criteria for follow-up visits.
Treatment A: 30g powdered GA in 100ml water, consumed daily
Dietary Supplement: Gum Arabic
Treatment B: 100ml water, consumed daily. Participants will follow their usual medications and lifestyle, randomized into two sequences (AB or BA).
Other: Water
Gum Arabic (Acacia seyal and Acacia senegal) 30g powdered GA in 100ml water, consumed daily.
100ml water, consumed daily
Change in mean average clearance of urea and creatinine in a full 24-hour urine collection.
To evaluate the effect of Gum Arabic (GA) on residual renal function in end stage renal disease (ESRD) patients on dialysis as measured by the achievement of at least 5 millilitres/minute improvement in mean average urea creatinine clearance.
Time frame: 3 months
Changes in urine volume
Evaluate changes in urine volume collected for 24 hours over long intradialytic period (ml)
Time frame: 3 months
Changes in serum lipids
Evaluate changes in serum cholesterol (mmol/l)
Time frame: 3 months
Changes in intradialytic weight gain.
Evaluate changes in intradialytic weight gain (kg)
Time frame: 3 months
Side effects bad enough to discontinue IP
Percentage of patients who have side effects that cause them to discontinue therapy.(%)
Time frame: 3 months
Changes in serum potassium
Serum potassium (mmol/l)
Time frame: 3 months
Exploratory end point
Analyze impacts on cardiac health ECG changes
Time frame: 3 months
Exploratory end point
Analyze impacts Fructosamines (mmol/l)
Time frame: 3 months
Plan to share: No
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Studies of the drug tested here: Gum Arabic
Abu Dhabi Health Services Company