A Phase 2 interventional study of Gum Arabic in Metabolic Syndrome in Postmenopausal Females, sponsored by University of Khartoum. Completed at 1 site in Sudan. Open to female participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by University of Khartoum · Phase 2, Interventional, and Treatment
Gum Arabic ingestion has been proved to decrease some of the inflammatory markers in some metabolic diseases that have an inflammatory background. Nevertheless, the mechanism/s by which it does so is uncertain. This study is targeting one of the postulated molecular mechanisms at genetic level that may help to understand how Gum Arabic exerts its effect .The effects of GA on Nuclear Factor Kappa Beta, P38 Mitogen Activated Protein (MAP) Kinase levels, and on the expression of inflammatory cytokines genes are going to be assessed in postmenopausal females with Metabolic Syndrome.
The Metabolic syndrome (MetS) is a collection of several interconnected biochemical, clinical, and metabolic factors that directly increase the risk of atherosclerotic cardiovascular disease and Diabetes Mellitus.
Hypertension, Dyslipidemia, insulin resistance, obesity, glucose intolerance, proinflammatory and prothrombotic states are the cornerstone features defining the syndrome. Glycerol, free fatty acids (FFA), tumor necrosis factor alpha (TNFα), interleukin 6 (IL6), interleukin 1(IL-1) and Interferon Gamma (INFγ) are some of the inflammatory substances (cytokines) that are released from different cells (monocytes and adipocytes) in MetS.
Gum Arabic is found as a mixture of sodium, calcium and potassium salts of branched polysaccharides. In the colon, GA is fermented by colonic bacteria into short chain fatty acids such as butyrate, which are partially absorbed into blood.
Butyrate treatment was found to inhibit expression of cytokine mRNAs in peripheral blood monocytes (PBMC) that are stimulated by bacterial lipopolysaccharide (LPS).
In unstimulated (PBMC), a transcription factor (Nuclear Factor kappa β (NF-κB)) controls gene expression of some inflammatory cytokines; Tumor Necrosis Factor Alpha (TNF- α), IL-1 and IL-6. NF-κB was detected mainly in the cytoplasm tightly bound to an Inhibitory protein (IκB).
When those cells are stimulated by bacterial lipopolysaccharide (LPS) or by adipokines, NFκB is activated and translocates to the nucleus to start gene expression of the inflammatory cytokines. Moreover; stimulation causes degradation of IκB which releases NFκB and allows its translocation to the nucleus.
This nuclear translocation of NFκB was found to be inhibited by butyrate (a byproduct of Gum Arabic fermentation ) providing evidence that butyrate mediated reduction of proinflammatory cytokines was achieved by reducing NFκB activation.
Consequently; the postulated mechanisms by which butyrate may regulate gene expression are through inhibition of NFκB activation and IκBα degradation.
NFκB and the inflammatory cytokines: Target for therapy in inflammatory diseases, are they?
As NFκB is involved in transcriptional regulation of many cytokines genes that contributes to immune and inflammatory responses, it may be a good target for therapy also. At present, treatment of inflammatory diseases depends greatly on aminosalicylates, corticosteroids, and immune-suppressants that decrease cytokines level especially TNF.
The anti-inflammatory and immune-modulatory properties of gum Arabic, through butyrate, described previously may offer an interesting alternative therapeutic approach for inflammatory conditions.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Khartoum is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hundred postmenopausal women were enrolled and received therapeutic dose of Gum Arabic (0.5 gm/kg/day) and followed for 12 weeks then the intended outcomes will be compared before and after completion of the study
Drug: Gum Arabic
A dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414))
Also known as: Acacia Senegal
Nuclear Factor Kappa Beta concentration in nanogram/dl
Nuclear regulatory protein
Time frame: 12 weeks
P38 Mitogen activated protein kinase in nanogram/dl
Transcription regulatory protein
Time frame: 12 weeks
Inhibitory Kappa Beta protein in nanogram/dl
inhibitory protein
Time frame: 12 weeks
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
Proinflammatory cytokines
Time frame: 12 weeks
Plasminogen activated protein inhibitor1 in picogram/dl
Protein Inhibitor
Time frame: 12 weeks
Fasting Insulin in nanogram/dl
Metabolic hormone
Time frame: 12 weeks
Insulin resistance by HOMA index
Measuring cells sensitivity to insulin
Time frame: 12 weeks
Fasting Blood Sugar in mg/dl
Biochemical serological markers
Time frame: 12 weeks
Lipid profile in mg/dl
Serological markers
Time frame: 12 weeks
waist circumference in cm
Anthropometric measurement
Time frame: 12 weeks
Ran from Dec 2019 to primary completion in Jan 2021, 13 months.
Of 28 non-industry phase 2 interventional studies under Metabolic Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 62. This study's 13 months is below that.
Counting every sponsor, half of 31 studies reached it within 29 months; a quarter within 18 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gum Arabic
University of Khartoum