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

NCT06836206 | Recruiting Phase 1 DMC

• 1 other identifier: HREC SEHA-IRB- 814
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease (ESRD)

Keywords

Gum Arabic; ESRD; Acacia seyal and Acacia senegal

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (5)

• Changes in urine volume

  3 months

• Changes in serum lipids

  3 months

• Changes in intradialytic weight gain.

  3 months

• Side effects bad enough to discontinue IP

  3 months

• Changes in serum potassium

  3 months

Other Outcomes (2)

• Exploratory end point

  3 months

• Exploratory end point

  3 months

Study Arms (2)

Treatment A: 30g powdered GA in 100ml water, consumed daily

EXPERIMENTAL

Treatment A: 30g powdered GA in 100ml water, consumed daily

Dietary Supplement: Gum Arabic

Treatment B: 100ml water, consumed daily.

OTHER

Treatment B: 100ml water, consumed daily. Participants will follow their usual medications and lifestyle, randomized into two sequences (AB or BA).

Other: Water

Interventions

Gum Arabic DIETARY_SUPPLEMENT

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

Treatment A: 30g powdered GA in 100ml water, consumed daily

Water OTHER

100ml water, consumed daily

Treatment B: 100ml water, consumed daily.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abu Dhabi Health Services Company: lead

Study Sites (1)

SEHA Kidney Care (SKC)

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (14)

• 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.

  PMID: 15269196 BACKGROUND

• 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.

  PMID: 3692386 BACKGROUND

• 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.

  PMID: 6683227 BACKGROUND

• 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.

  PMID: 19479191 BACKGROUND

• 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.

  PMID: 32328307 BACKGROUND

• 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.

  PMID: 28589039 BACKGROUND

• 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.

  PMID: 17999333 BACKGROUND

• 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.

  PMID: 24022265 BACKGROUND

• 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.

  PMID: 23241359 BACKGROUND

• 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.

  PMID: 33435475 BACKGROUND

• 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.

  PMID: 36092515 BACKGROUND

• 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.

  PMID: 36671523 BACKGROUND

• 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.

  PMID: 35208961 BACKGROUND

• 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.

  PMID: 33896052 BACKGROUND

Related Links

• Gum Arabic in renal disease (GARDS Study): Clinical evidence of dietary supplementation impact on progression of renal dysfunction
• Efficacy and Safety of Gum Arabic on Renal Failure Patients: Systematic Review and Meta-analysis
• Al-Yahya AA, Asad M. Antiulcer activity of gum Arabic and its interaction with antiulcer effect of ranitidine in rats. Biomedical Research (India). 2016;27(4).

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Gum Arabic; Water

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Stephen G Holt, MD

  Abu Dhabi Health Services Co. -SEHA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen G Holt, MD

CONTACT

+971 2 711 7444; sholt@seha.ae

Edward R Smith, PhD

CONTACT

esmith@seha.ae

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SEHA Kidney Care (SKC) Professor Director

Model Details: 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

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 20, 2025
• Study Start: February 3, 2025
• Primary Completion: November 30, 2025
• Study Completion: April 30, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)