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End Stage Renal Disease (ESRD)Phase 1/2GAESRDNCT06836206

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

A Phase 1/2 study testing Gum Arabic and Water in people with End Stage Renal Disease (ESRD), run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease (ESRD)
What is being tested?
Gum Arabic and Water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Arab Emirates
Study dates
3 Feb 2025to 30 Apr 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible to participate in this trial, an individual must meet all the following criteria:
  • 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.
  • 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.
  • 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.
  • Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
  • 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.

Who cannot join

  • Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
  • Women Pregnant or lactating
  • Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
  • Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
  • Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
  • Peritoneal dialysis.
Show all 14Show fewer
  • Kidney transplant or booked for a live transplant within 259 days of randomization.
  • Patients gaining >4 kg between dialysis sessions in the past 2 weeks.
  • People with known allergies to quillaja bark or similar tree bark.
  • Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials).
  • Patients on immunosuppression for kidney transplant.
  • Additional exclusion criteria for follow-up visits.
  • Patient informs of pregnancy.
  • Severe adverse reaction to the interventional product.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stephen G Holt, MD contact

+971 2 711 7444

sholt@seha.ae

Edward R Smith, PhD contact

esmith@seha.ae

United Arab Emirates1 site, 1 recruiting

  • SEHA Kidney Care (SKC)

    Abu Dhabi

    Ayman I Allaham, MS, +971 2 711 7472, aibrahim@seha.ae

    Alina Naeem, MBBS, alnaeem@seha.ae

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: 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.

Read the 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.

Being tested
Gum Arabic, Water
Keywords
Gum Arabic, ESRD, Acacia seyal and Acacia senegal
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gum ArabicDietary supplement

    Gum Arabic (Acacia seyal and Acacia senegal) 30g powdered GA in 100ml water, consumed daily.

  • WaterOther

    100ml water, consumed daily

Study groups in NCT06836206
Study groupRoleWhat they receive
Treatment A: 30g powdered GA in 100ml water, consumed dailyExperimentalTreatment A: 30g powdered GA in 100ml water, consumed daily
Receives: Dietary Supplement: Gum Arabic
Treatment B: 100ml water, consumed daily.OtherTreatment B: 100ml water, consumed daily. Participants will follow their usual medications and lifestyle, randomized into two sequences (AB or BA).
Receives: Other: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (5)

  1. Changes in urine volume

    Evaluate changes in urine volume collected for 24 hours over long intradialytic period (ml)

    Measured: 3 months

  2. Changes in serum lipids

    Evaluate changes in serum cholesterol (mmol/l)

    Measured: 3 months

  3. Changes in intradialytic weight gain.

    Evaluate changes in intradialytic weight gain (kg)

    Measured: 3 months

  4. Side effects bad enough to discontinue IP

    Percentage of patients who have side effects that cause them to discontinue therapy.(%)

    Measured: 3 months

  5. Changes in serum potassium

    Serum potassium (mmol/l)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start3 Feb 2025
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Open-label, randomized, crossover trial Intervention: Treatment A: Gum Arabic (Acacia seyal and Acacia senegal) in 100ml water Treatment B: Water 100ml Patients will receive either treatment A or B for 3 months followed by a washout then the other arm of therapy. ie randomized to the treatment sequence AB or BA
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06836206
Sponsor's protocol ID
HREC SEHA-IRB- 814
Acronym
GAESRD
Status last verified
Feb 2025
First submitted
30 Jan 2025
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eltayeb IB, Awad AI, Elderbi MA, Shadad SA. Effect of gum arabic on the absorption of a single oral dose of amoxicillin in healthy Sudanese volunteers. J Antimicrob Chemother. 2004 Aug;54(2):577-8. doi: 10.1093/jac/dkh372. Epub 2004 Jul 21. No abstract available.

    PubMed 15269196

  • Collins TF, Welsh JJ, Black TN, Graham SL, O'Donnell MW Jr. Study of the teratogenic potential of guar gum. Food Chem Toxicol. 1987 Nov;25(11):807-14. doi: 10.1016/0278-6915(87)90258-4.

    PubMed 3692386

  • Melnick RL, Huff J, Haseman JK, Dieter MP, Grieshaber CK, Wyand DS, Russfield AB, Murthy AS, Fleischman RW, Lilja HS. Chronic effects of agar, guar gum, gum arabic, locust-bean gum, or tara gum in F344 rats and B6C3F1 mice. Food Chem Toxicol. 1983 Jun;21(3):305-11. doi: 10.1016/0278-6915(83)90065-0.

    PubMed 6683227

  • Al Mosawi AJ. Six-year dialysis freedom in end-stage renal disease. Clin Exp Nephrol. 2009 Oct;13(5):494-500. doi: 10.1007/s10157-009-0181-7. Epub 2009 May 30.

    PubMed 19479191

  • Ali NE, Kaddam LA, Alkarib SY, Kaballo BG, Khalid SA, Higawee A, AbdElhabib A, AlaaAldeen A, Phillips AO, Saeed AM. Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial. Int J Nephrol. 2020 Apr 9;2020:7214673. doi: 10.1155/2020/7214673. eCollection 2020.

    PubMed 32328307

  • Elamin S, Alkhawaja MJ, Bukhamsin AY, Idris MAS, Abdelrahman MM, Abutaleb NK, Housawi AA. Gum Arabic Reduces C-Reactive Protein in Chronic Kidney Disease Patients without Affecting Urea or Indoxyl Sulfate Levels. Int J Nephrol. 2017;2017:9501470. doi: 10.1155/2017/9501470. Epub 2017 May 14.

    PubMed 28589039

  • Ali AA, Ali KE, Fadlalla AE, Khalid KE. The effects of gum arabic oral treatment on the metabolic profile of chronic renal failure patients under regular haemodialysis in Central Sudan. Nat Prod Res. 2008 Jan 10;22(1):12-21. doi: 10.1080/14786410500463544.

    PubMed 17999333

  • Nasir O. Renal and extrarenal effects of gum arabic ( Acacia senegal )--what can be learned from animal experiments? Kidney Blood Press Res. 2013;37(4-5):269-79. doi: 10.1159/000350152. Epub 2013 Aug 11.

    PubMed 24022265

  • Babiker R, Merghani TH, Elmusharaf K, Badi RM, Lang F, Saeed AM. Effects of Gum Arabic ingestion on body mass index and body fat percentage in healthy adult females: two-arm randomized, placebo controlled, double-blind trial. Nutr J. 2012 Dec 15;11:111. doi: 10.1186/1475-2891-11-111.

    PubMed 23241359

  • Jarrar AH, Stojanovska L, Apostolopoulos V, Feehan J, Bataineh MF, Ismail LC, Al Dhaheri AS. The Effect of Gum Arabic (Acacia Senegal) on Cardiovascular Risk Factors and Gastrointestinal Symptoms in Adults at Risk of Metabolic Syndrome: A Randomized Clinical Trial. Nutrients. 2021 Jan 9;13(1):194. doi: 10.3390/nu13010194.

    PubMed 33435475

  • Gafar AM, Ramadan AM, ElSaid NA, Nurelhuda NM. Effect of Gum Arabic on plaque-induced gingivitis: A randomised controlled trial. Saudi Dent J. 2022 Sep;34(6):494-502. doi: 10.1016/j.sdentj.2022.06.002. Epub 2022 Jun 13.

    PubMed 36092515

  • Al-Jubori Y, Ahmed NTB, Albusaidi R, Madden J, Das S, Sirasanagandla SR. The Efficacy of Gum Arabic in Managing Diseases: A Systematic Review of Evidence-Based Clinical Trials. Biomolecules. 2023 Jan 9;13(1):138. doi: 10.3390/biom13010138.

    PubMed 36671523

  • Ashour MA, Fatima W, Imran M, Ghoneim MM, Alshehri S, Shakeel F. A Review on the Main Phytoconstituents, Traditional Uses, Inventions, and Patent Literature of Gum Arabic Emphasizing Acacia seyal. Molecules. 2022 Feb 9;27(4):1171. doi: 10.3390/molecules27041171.

    PubMed 35208961

  • Mayne TJ, Nordyke RJ, Schold JD, Weir MR, Mohan S. Defining a minimal clinically meaningful difference in 12-month estimated glomerular filtration rate for clinical trials in deceased donor kidney transplantation. Clin Transplant. 2021 Jul;35(7):e14326. doi: 10.1111/ctr.14326. Epub 2021 May 5.

    PubMed 33896052

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gum Arabic and Water in people with End Stage Renal Disease (ESRD), run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephen G Holt, MD (+971 2 711 7444, sholt@seha.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean average clearance of urea and creatinine in a full 24-hour urine collection. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06836206, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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