Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women

Effects of Gum Arabic Supplementation on the Components of Metabolic Syndrome Among Post Menopausal Females in Khartoum State 2019

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Syndrome in Postmenopausal Females
• Intervention / Treatment: Drug: Gum Arabic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sudan
  • Khartoum, Sudan, 11111
    • University of Khartoum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate

Exclusion Criteria:

• Exclusion criteria

  1. Patients with mental or physical disability
  2. Use of corticosteroids or any other drug that affects body weight
  3. History of Gum Arabic (GA) allergy
  4. Chronicrenal or liver disease
  5. Chronocinflammatory diseases
  6. History of CVA or MI Participants will be asked to maintain their habitually daily diet and level of activity during the period of the study and to continue any previously prescribed medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; 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)); Other Names: Acacia Senegal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nuclear Factor Kappa Beta concentration in nanogram/dl	Nuclear regulatory protein	12 weeks
P38 Mitogen activated protein kinase in nanogram/dl	Transcription regulatory protein	12 weeks
Inhibitory Kappa Beta protein in nanogram/dl	inhibitory protein	12 weeks
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl	Proinflammatory cytokines	12 weeks
Plasminogen activated protein inhibitor1 in picogram/dl	Protein Inhibitor	12 weeks
Fasting Insulin in nanogram/dl	Metabolic hormone	12 weeks
Insulin resistance by HOMA index	Measuring cells sensitivity to insulin	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Sugar in mg/dl	Biochemical serological markers	12 weeks
Lipid profile in mg/dl	Serological markers	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference in cm	Anthropometric measurement	12 weeks

Collaborators and Investigators

• Sponsor: University of Khartoum
• Collaborators: Ministry of Higher Education and Scientific Research, Republic of Sudan
• Investigators: Principal Investigator: Fatima Elhaj, Msc, lecturer in physiology department University of Khartoum; Principal Investigator: Shaza Elawad, MSc, lecturer in physiology department University of Khartoum

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): January 10, 2021
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: July 10, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Gum Arabic; Metabolic Syndrome; Inflammatory markers
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: NMPB/0047815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No