Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women

NCT04978103 | Completed Phase 2 DMC

• 1 other identifier: NMPB/0047815
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome in Postmenopausal Females

Keywords

Gum Arabic; Inflammatory markers; Metabolic Syndrome

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Fasting Blood Sugar in mg/dl

  12 weeks

• Lipid profile in mg/dl

  12 weeks

Other Outcomes (1)

• waist circumference in cm

  12 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Gum Arabic DRUG

A dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414))

Also known as: Acacia Senegal

Single Arm

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: postmenopausal females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with mental or physical disability
• Use of corticosteroids or any other drug that affects body weight
• History of Gum Arabic (GA) allergy
• Chronicrenal or liver disease
• Chronocinflammatory diseases
• 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.

Sponsors & Collaborators

• University of Khartoum: lead
• Ministry of Higher Education and Scientific Research, Republic of Sudan: collaborator

Study Sites (1)

University of Khartoum

Khartoum, 11111, Sudan

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Fatima Elhaj, PhD

  lecturer in physiology department University of Khartoum

  PRINCIPAL INVESTIGATOR

• Shaza Elawad, MSc

  lecturer in physiology department University of Khartoum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Both the investigators and outcome assessors will be given codes of the participants for further analysis
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Postmenopausal females are randomly selected to receive Gum Arabic treatment and intended outcomes will be measured before and after the intervention

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 27, 2021
• Study Start: December 4, 2019
• Primary Completion: January 10, 2021
• Study Completion: December 20, 2022
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

SU (1)