Dataset Information

Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial.

ABSTRACT: Background:Oxidative processes might increase in patients with end-stage renal disease (ESRD) according to the current literature. Oxidative stress (OS) is a risk factor of atherosclerosis and cardiovascular complications, which are major causes of mortality among ESRD patients. Haemodialysis (HD) is life-saving procedure, nevertheless it is an active chronic inflammatory status that could augment cardiovascular disease and increase mortality. Gum Arabic (GA) has been claimed to act as an antioxidant and anti-inflammatory agent in experimental studies and clinical trials. Therefore, we assumed GA supplementation among haemodialysis patients would reduce oxidative stress and consequently reduce the state of chronic inflammatory activation associated with haemodialysis. Methods:Forty end-stage renal failure (ESRF) patients aged 18-80 years who were on regular haemodialysis in Arif Renal Center, Omdurman, Sudan, were recruited. All recruited patients met the inclusion criteria and signed informed consent prior to enrolment. The patients received 30?g/day of GA for 12 weeks. C-reactive protein (CRP) and complete blood count (CBC) were measured as baseline and monthly. Total antioxidant capacity (TAC) and oxidative stress marker malondialdehyde (MDA) levels were measured before and after GA intake. Ethical approval from the National Medicines and Poisons Board was obtained. Results:Gum Arabic significantly augmented total antioxidant capacity level (P < 0.001) (95% CI, 0.408-0.625) and also attenuated oxidative marker MDA and C-reactive protein (P < 0.001). Conclusions:GA has revealed potent antioxidative and anti-inflammatory properties in haemodialysis patients. Oral digestion of GA (30?g/day) decreased oxidative stress and inflammatory markers among haemodialysis patients. Trial registration. ClinicalTrials.gov Identifier: NCT03214692, registered 11 July 2017 (prospective registration).

SUBMITTER: Ali NE

PROVIDER: S-EPMC7171621 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Gum Arabic (<i>Acacia Senegal</i>) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial.

Ali Nour Elkhair NE Kaddam Lamis AbdelGadir LA Alkarib Suad Yousif SY Kaballo Babikir Gabir BG Khalid Sami Ahmed SA Higawee Abdalazim A AbdElhabib Alaa A AlaaAldeen Alaa A Phillips Aled O AO Saeed Amal Mahmoud AM

International journal of nephrology 20200409

<h4>Background</h4>Oxidative processes might increase in patients with end-stage renal disease (ESRD) according to the current literature. Oxidative stress (OS) is a risk factor of atherosclerosis and cardiovascular complications, which are major causes of mortality among ESRD patients. Haemodialysis (HD) is life-saving procedure, nevertheless it is an active chronic inflammatory status that could augment cardiovascular disease and increase mortality. Gum Arabic (GA) has been claimed to act as a ...[more]

PMID: 32328307

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Project description:BackgroundSickle cell disease (SCD) is an inherited haemolytic anemia with a variable course and severity. Knowledge of prognostic biomarkers may help in the establishment of therapeutic intervention, management, and follow-up of patients. There have been scattered reports of low high-density lipoprotein cholesterol (HDL-C) and increased triglyceride (TG) in SCD patients. In addition, TG levels have been suggested to be elevated in patients with increased endothelial activation. An increased TG level has been associated with haemolysis, vascular dysfunction, and increased prevalence of pulmonary hypertension. Gum Arabic (GA) is an edible, dried, gummy exudate from the acacia Senegal tree. Several studies on GA ingestion have shown reduced plasma cholesterol and low-density lipoprotein (LDL) concentrations in both animals and humans. We investigated GA's therapeutic potential to modulate serum lipids in patients with sickle cell anemia.MethodsThis study recruited and documented secondary outcomes in 47 patients (aged 5-42 years) carrying hemoglobin SS. The patients received 30 g/day of GA for 12 weeks. Total cholesterol, TG, LDL, and HDL were measured before and after GA intake. Cobas C311 (Roche, Germany) automated chemistry analyser was used for direct determination of the values of the lipid profile.ResultsGA significantly decreased total cholesterol (TC), TG, and LDL (p = 0.006, 0.04, and 0.02, resp.). GA showed no effect on HDL level. Baseline serum TG and LDL correlated significantly with the hydrogen peroxide (H2O2) level, which is known as an oxidative stress marker (p = 0.003 and 0.04, resp.). None of the lipid profile elements correlated with age.ConclusionOur results revealed that dyslipidemia in sickle cell patients is associated with oxidative stress but not associated with age. The findings showed that GA significantly decreased TC, LDL, and TG levels, revealing a novel effect of GA, which is considered a natural dietary fibre that can modulate lipid profile in patients with sickle cell anemia.Trial registrationThis retrospective trial is registered with ClinicalTrials.gov Identifier: NCT02467257 on 3 June, 2015.

Project description:ObjectivesTo investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. To study the effect of GA on the level of cytokines, TNFα, IL8, IL6 IL10, CRP and the viral load. Secondary outcomes will be the effect of GA oral intake on mortality rate and days of hospital admission.Trial designQuadruple blind, randomized placebo-controlled clinical trial Phase II & III. Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio) superiority trial of oral GA among seropositive COVID-19 patients.ParticipantsInclusion criteria: COVID-19 infected (newly diagnosed) as proved by real-time PCR within 72 hours of PCR. Age 8-90 years Both genders Exclusion criteria: Intubated patients on parenteral treatment Allergy to Gum Arabic The study will be conducted in COVID Isolation Centres and Soba University Hospital Khartoum State Sudan.Intervention and comparatorExperimental: Intervention Group This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose once daily for four weeks Placebo Comparator: Control group: This group will be provided with pectin powder provided as one-gram-dose once daily for four weeks Both GA and placebo will be in addition to standard care treatment based on local clinical guidelines.Main outcomesMean change from baseline score of Immune Response to end of the trial. Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization). Mortality rate: The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo (Four weeks from the start of randomization]).RandomisationRandomization (1:1 allocation ratio) and will be conducted using a sequence of computer-generated random numbers by an independent individual. Each participating centre will be assigned a special code generated by the computer. The randomization will be kept by the PI and a research assistant.Blinding (masking)Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 110 eligible patients will be randomly assigned to either GA (n=55) or placebo (n=55) groups.Trial statusProtocol Version no 2, 30th June 2020. Recruitment will start on 15th September 2020. The intended completion date is 15th January 2021.Trial registrationClinicalTrials.gov Identifier: NCT04381871 . Date of trial registration: 11 May 2020.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Dataset Information

Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial.

Publications

Gum Arabic (<i>Acacia Senegal</i>) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial.

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