Faculty of Medicine and Surgery
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Item Effect of Gum Arabic (Acacia Senegal) supplementation on visceral adiposity index (VAI) and blood pressure in patients with type 2 diabetes mellitus as indicators of cardiovascular disease (CVD): a randomized and placebo-controlled clinical trial(Lipids in Health and Disease, 2018) Babiker, Rasha; Elmusharaf, Khalifa; Keogh, Michael B.; Saeed, Amal M.Background: There is a strong association between cardiometabolic risk and adipose tissue dysfunction with great consequences on type 2 diabetic patients. Visceral Adiposity Index (VAI) is an indirect clinical marker of adipose tissue dysfunction. Gum Arabic (GA) is a safe dietary fiber, an exudate of Acacia Senegal. Gum Arabic had shown lipid lowering effect in both humans and animals. The aim of this trial was to determine the effect of GA supplementation on anthropometric obesity marker, Visceral Adiposity Index (VAI) and blood pressure in patients with type 2 diabetes mellitus. Methods: This randomized, double blinded, placebo controlled trial recruited a total of 91 type 2 diabetic patients (73 females, 18 males), age (mean ±SD) 50.09±9.3 years on hypoglycemic agents and were randomly assigned into two groups, either to consume 30 g of GA or 5 g of placebo daily for 3 months. Anthropometric obesity markers were measured and indices were calculated. Blood pressure was measured and high density lipoprotein (HDL) and triglycerides (TG) were determined in fasting blood samples at the start and end of the study period. Results: After intervention, Gum Arabic decreased BMI and VAI significantly (P < 0.05) in GA group by 2 and 23.7% respectively. Body adiposity index significantly decreased by 3.9% in GA group while there were no significant changes in waist circumference or waist-to-hip ratio (WHR). Systolic blood pressure significantly decreased by 7.6% in GA group and by 2.7% in placebo group from baseline with no significant changes in diastolic blood pressure in the two groups. Conclusion: Gum Arabic consumption at a dose of 30 g/d for 3 months may play an effective role in preventing weight gain and modulating adipose tissue dysfunction in type 2 diabetic patients, although no effect has been shown in waist-to-hip ratioItem 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(Nutrition Journal, 2012) Babiker,Rasha; Merghani,Tarig H; Elmusharaf,Khalifa; Badi,Rehab M; Lang,Florian; Saeed,Amal MBackground: Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals. It has been considered as a safe dietary fiber by the United States, Food and Drug Administration (FDA) since the 1970s. Although its effects were extensively studied in animals, there is paucity of data regarding its quantified use in humans. This study was conducted to determine effects of regular Gum Arabic (GA) ingestion on body mass index and body fat percentage among healthy adult females. Methods: A two-arm randomized, placebo controlled, double-blind trial was conducted in the Department of Physiology at the Khartoum University. A total of 120 healthy females completed the study. They were divided to two groups: A test group of 60 volunteers receiving GA (30 gm /day) for 6 weeks and a placebo group of 60 volunteers receiving pectin (1 gm/day) for the same period of time. Weight and height were measured before and after intervention using standardized height and weight scales. Skin fold thickness was measured using Harpenden Skin fold caliper. Fat percentage was calculated using Jackson and Pollock 7 caliper method and Siri equation. Results: Pre and post analysis among the study group showed significant reduction in BMI by 0.32 (95% CI: 0.17 to 0.47; P<0.0001) and body fat percentage by 2.18% (95% CI: 1.54 to 2.83; P<0.0001) following regular intake of 30 gm /day Gum Arabic for six weeks. Side effects caused by GA ingestion were experienced only in the first week. They included unfavorable viscous sensation in the mouth, early morning nausea, mild diarrhea and bloating abdomen. Conclusions: GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females. The effect could be exploited in the treatment of obesity.Item Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trial(2020) Kaddam,Lamis; Babiker,Rasha; Ali,Sara; Satti,Shahinaz; Ali,Nour; Elamin,Maha; Mukhtar,Mowaia; Elnimeiri,Mustafa; Saeed,AmalObjectives: To 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 design: Quadruple 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. Participants: Inclusion 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 comparator: Experimental: Intervention Group (Continued on next page) 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 outcomes: Mean 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]). Randomisation: Randomization (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 Status: Protocol Version no 2, 30th June 2020. Recruitment will start on 15th September 2020. The intended completion date is 15th January 2021. Trial registration: ClinicalTrials.gov Identifier: NCT04381871. Date of trial registration: 11 May 2020. Full protocol: The 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.Item Metabolic effects of Gum Arabic (Acacia Senegal) in patients with Type 2 Diabetes Mellitus (T2DM): Randomized, placebo controlled double blind trial(2017) Babiker,Rasha; Elmusharaf,Khalifa; Keogh,Michael B; Banaga,Amin S. I; Saeed,Amal MBackground: Gum Arabic (GA) is a water-soluble dietary fiber, indigestible to both humans and animals. While GA currently does not have any therapeutic potential, it has nutritional value and some effects on metabolism of glucose and lipids. Thus, the aim of this study is to assess the effect of GA on serum level of glucose, lipids, and the BMI in type 2 diabetic patients. Methods: A double-blind randomized placebo-controlled trial took place at Academy Charity Teaching Hospital (ACTH) in Sudan between August 2014 to February 2015. The trial was conducted in type 2 diabetic patients who were on regular oral hypoglycemic drugs and had HbA1C ≥ 6.5%. Patients excluded from the study included those on insulin, any patient with a metabolic or gastrointestinal disease, and any patient with history of drug addiction and alcoholism. Other patients excluded were patients who had previous allergic reactions to GA in addition to patients who were pregnant or planned for conception within 6 months. 120 patients were invited to participate in this trial. 100 patients gave consent and were randomized to GA and placebo groups. The GA group was given 30 g of Acacia Senegal and the placebo group was given 5 g of placebo daily for 3 months. The outcomes assessed were primarily the effect of GA on glucose levels in addition to the effects on levels of lipids and BMI in type 2 diabetic patients. Results: The GA group showed significant reduction in fasting plasma glucose (FPG) and HbA1c (P<0.05) within the GA group. Moreover, GA supplementation improved lipid profiles; decreased LDL-Cholesterol by 5.95%, total Cholesterol by 8.28% and triglyceride by 10.95% from baseline levels. HDL-Cholesterol showed significant increase by 19.89% within GA group (P<0.05), BMI was decreased significantly by 2.06% (95% CI: −0.98; −0.16), P<0.05). Conclusions: Gum Arabic is a dietary supplement for improving nutrition of type 2 diabetic patients; it has demonstrated a good effect on improving their poor glycemic control. It has also shown improvement in the levels of the lipids and the BMI. Further studies are needed in obese and pre-diabetic patients to evaluate GA therapeutic potentials.Item 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(Nutrition Journal, 2012) Babiker, Rasha; Merghani, Tarig H; Elmusharaf, Khalifa; Badi, Rehab M; Lang, Florian; Saeed, Amal MBackground: Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals. It has been considered as a safe dietary fiber by the United States, Food and Drug Administration (FDA) since the 1970s. Although its effects were extensively studied in animals, there is paucity of data regarding its quantified use in humans. This study was conducted to determine effects of regular Gum Arabic (GA) ingestion on body mass index and body fat percentage among healthy adult females. Methods: A two-arm randomized, placebo controlled, double-blind trial was conducted in the Department of Physiology at the Khartoum University. A total of 120 healthy females completed the study. They were divided to two groups: A test group of 60 volunteers receiving GA (30 gm /day) for 6 weeks and a placebo group of 60 volunteers receiving pectin (1 gm/day) for the same period of time. Weight and height were measured before and after intervention using standardized height and weight scales. Skin fold thickness was measured using Harpenden Skin fold caliper. Fat percentage was calculated using Jackson and Pollock 7 caliper method and Siri equation. Results: Pre and post analysis among the study group showed significant reduction in BMI by 0.32 (95% CI: 0.17 to 0.47; P<0.0001) and body fat percentage by 2.18% (95% CI: 1.54 to 2.83; P<0.0001) following regular intake of 30 gm /day Gum Arabic for six weeks. Side effects caused by GA ingestion were experienced only in the first week. They included unfavorable viscous sensation in the mouth, early morning nausea, mild diarrhea and bloating abdomen. Conclusions: GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females. The effect could be exploited in the treatment of obesity.