Gum Arabic as Antioxidant and Anti-inflammatory in Hemodialysis Patients

End-Stage Renal Disease Clinical Trial

— GA&CRF  

Official title:

Potential Role of Gum Arabic as Antioxidant and Anti-inflammatory Agent in Hemodialysis Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03214692
• Other study ID #: GA&CRF
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 18, 2017
• Last updated: July 10, 2017
• Start date: July 2017
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: Al-Neelain University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oxidative processes increased in patients with renal failure and especially patients with end stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is claimed to have antioxidant effect and this will decrease the harmful effect of the free radical on patient on hemodialysis. In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.

Description:

The oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.

Cells continuously produce free radicals and reactive oxygen species (ROS) as part of metabolic processes. These free radicals are neutralized by an elaborate antioxidant defense system consisting of enzymes such as catalase, superoxide dismutase, glutathione peroxidase, and numerous non-enzymatic antioxidants, including vitamins A, E and C and glutathione.

Oxidative stress has been linked to the pathogenesis of a variety of diseases, such as renal disease, cardiovascular disease, atherosclerosis, hypertension, cancer, diabetes, arthritis neurodegenerative diseases (i.e., Alzheimer's and Parkinson's disease), and aging.

The prevalence and incidence of patient suffering from chronic renal failure is increasing worldwide and locally in Sudan(5). Several publication suggest that oxidative processes may be increased in patients with renal failure. As oxidative stress plays a role in renal damage it offers a potential target for therapeutic intervention.

There is a lot of factors that can lead to oxidative stress in patients with chronic kidney disease (CKD) . Intravenous administration of iron is widely prescribed in patients with chronic kidney disease (CKD) and can cause oxidative stress.Hemodialysis is often used for removal of excessive toxins, metabolic products, and blood components from patients with end-stage renal diseases (ESRD). Clinical studies have confirmed that hemodialysis (HD) is associated with the development of oxidative stress and disturbance in the enzyme systems that protect against oxygen free radicals.

The major cause of mortality in patients with end-stage renal failure receiving renal replacement therapy is cardiovascular disease . Cardiovascular disease (CVD) is the cause of death in 34% of hemodialysis (HD) patients. Increased lipid peroxidation and depletion of chain- breaking antioxidants may contribute to increased risk of atherosclerosis.

Antioxidants have been used as therapies to decrease oxidative stress and improve CVD risk in hemodialysis (HD) Patients .Many studies investigated the effects of antioxidant therapies on biomarkers of oxidative stress or clinical outcomes. The majority were small trials using a nonrandomized open-label design with a single HD group (no HD controls). The antioxidant used were Alpha-tocopherol , vitamin c decreased oxidative stress and N-acetylcysteine . N-acetylcysteine was the most efficacious agent. Others studies have used a combination of antioxidants that decreased oxidative stresses. Most of these intervention studies were done in HD patients .

Gum arabic is defined by the FAO/WHO Joint Expert Committee for Food Additives (JECFA) as 'a dried exudation obtained from the stems of Acacia Senegal tree or closely related species of Acacia (family Leguminosae).

GA is indigestible for both human and animals; Its fermentation by colonic intestinal bacteria leads to formation of various degradation products, such as short-chain fatty acids .Gum Arabic ingestion increases serum short chain fatty acid concentration, mainly butyrate and propionate. Serum butyrate concentration increased following administration of GA in healthy subjects. Oral intake of GA has been shown to provide several health benefits, such as prebiotic effects. GA significantly increases Bifidobacteria, Lactobacteria, and Bacteriodes in the gut. GA is claimed to have anti-cancer ,anti-malarial immune-modulatory and antioxidant effects. GA treatment has been shown to favorably influence clinical and laboratory results in rats with adenine-induced chronic renal failure CRF and in humans diagnosed with renal failure, reported that GA was able to decrease high levels of several pro-inflammatory cytokines in plasma and kidney of rats suffering from adenine-induced CRF.

The antioxidant effect of Gum Arabic has been observed in Number of published data .

More recently 2017 reported more evidence that GA has potent anti- oxidative effects in humans as demonstrated by its ability to increase TAC and to decrease oxidative stress markers in humans, Almost all previous studies were conducted in animal models or in vitro studies except the last one(17) . the increased intake of dietary antioxidants from GA may help to maintain an adequate antioxidant defense status . GA can be utilized in other clinical conditions and diseases caused by increased lipid peroxidation and tissue injury.

In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• End stage renal disease patients on regular hemodialysis.

Exclusion Criteria:

• Patient known have ischemic heart disease (coronary artery disease),

• Pregnant women,

• Patient who have impaired liver function or hepatitis VIRUS positive,

• Patient who HIV positive and patient currently use of GUM Arabic.

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• Gum Arabic
Oral intake of GA in powder from30 grams per day

Locations

Country	Name	City	State
Sudan	Military Hospital AlshaheedArif renal center	Khartoum	Umdorman

Sponsors (3)

Lead Sponsor	Collaborator
Lamis Kaddam	Military Hospital Sudan, University of Khartoum

Country where clinical trial is conducted

Sudan, 

References & Publications (2)

Ali BH, Al-Husseni I, Beegam S, Al-Shukaili A, Nemmar A, Schierling S, Queisser N, Schupp N. Effect of gum arabic on oxidative stress and inflammation in adenine-induced chronic renal failure in rats. PLoS One. 2013;8(2):e55242. doi: 10.1371/journal.pone. — View Citation

Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Salih MA, Lang F, Saeed AM. Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial. BMC Hematol. 2017 Mar 16;17:4. doi: 10.1186/s12878-017-0075-y. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Tumor necrosis factor alpha	pg/mL	Baseline and after 12 weeks
Primary	Change from baseline Oxidative stress marker malondialdehyde	nmol/mL	Baseline and after 12 weeks
Secondary	Glomerular Filtration Rate (GFR)	ml/ minute	Baseline and every four weeks for 12 weeks