The Effect of Gum Arabic (GA) on Residual Renal Function in Adult Dialysis Patients in Abu Dhabi (GAESRD)

February 14, 2025 updated by: Stephen Geoffrey Holt, Abu Dhabi Health Services Company

The Effect of Gum Arabic (GA) on Adult Dialysis Patients in Abu Dhabi: a Prospective Randomized-controlled Trial (The GADAD Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephen G Holt, MD
  • Phone Number: +971 2 711 7444
  • Email: sholt@seha.ae

Study Contact Backup

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • SEHA Kidney Care (SKC)
        • Contact:
        • Contact:
        • Contact:
          • Edward R Smith, PhD
        • Contact:
          • Stephen G Holt, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To be eligible to participate in this trial, an individual must meet all the following criteria:

  1. Men and women ≥18 years of age with diagnosed ESRD and prescribed regular dialysis at least once a week, weekly at least for past two weeks.
  2. For past two weeks including women of childbearing potential who are currently adopting any method of contraception or have completed the family and undergone sterilization procedures and women of non-childbearing potential.
  3. Patients with residual renal function - Patients who produce a minimum of 200 ml of urine during a full day of collection (A full day collection: the patient discards the first urine sample on the day of collection then collects all urine for the entire day and night and collects the first urine sample of the next day) r on a non-dialysis long break day.
  4. Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
  5. With the ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
  2. Women Pregnant or lactating
  3. Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
  4. Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
  5. Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
  6. Peritoneal dialysis.
  7. Kidney transplant or booked for a live transplant within 259 days of randomization.
  8. Patients gaining >4 kg between dialysis sessions in the past 2 weeks.
  9. People with known allergies to quillaja bark or similar tree bark.
  10. Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials).
  11. Patients on immunosuppression for kidney transplant.

Additional exclusion criteria for follow-up visits.

  1. Patient informs of pregnancy.
  2. Severe adverse reaction to the interventional product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A: 30g powdered GA in 100ml water, consumed daily
Dietary supplement: Gum Arabic
Gum Arabic (Acacia seyal and Acacia senegal) 30g powdered GA in 100ml water, consumed daily.
Other: Treatment B: 100ml water, consumed daily.
Treatment B: 100ml water, consumed daily. Participants will follow their usual medications and lifestyle, randomized into two sequences (AB or BA).
Other: Water
100ml water, consumed daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean average clearance of urea and creatinine in a full 24-hour urine collection.
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in urine volume
Time Frame: 3 months
Evaluate changes in urine volume collected for 24 hours over long intradialytic period (ml)
3 months
Changes in serum lipids
Time Frame: 3 months
Evaluate changes in serum cholesterol (mmol/l)
3 months
Changes in intradialytic weight gain.
Time Frame: 3 months
Evaluate changes in intradialytic weight gain (kg)
3 months
Side effects bad enough to discontinue IP
Time Frame: 3 months
Percentage of patients who have side effects that cause them to discontinue therapy.(%)
3 months
Changes in serum potassium
Time Frame: 3 months
Serum potassium (mmol/l)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory end point
Time Frame: 3 months
Analyze impacts on cardiac health ECG changes
3 months
Exploratory end point
Time Frame: 3 months
Analyze impacts Fructosamines (mmol/l)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abu Dhabi Health Services Company

Investigators

  • Principal Investigator: Stephen G Holt, MD, Abu Dhabi Health Services Co. -SEHA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC SEHA-IRB- 814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease (ESRD)

Clinical Trials on Gum Arabic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe