Metabolic Syndrome in Postmenopausal FemalesPhase 2NCT04978103
Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women
A Phase 2 study testing Gum Arabic in people with Metabolic Syndrome in Postmenopausal Females, run by University of Khartoum at 1 site in Sudan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Metabolic Syndrome in Postmenopausal Females
- What is being tested?
- Gum Arabic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSudan
- Study dates
- 4 Dec 2019to 20 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Gum Arabic
- Keywords
- Gum Arabic, Inflammatory markers, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum ArabicDrug
Also called Acacia Senegal
A dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414))
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Gum Arabic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nuclear Factor Kappa Beta concentration in nanogram/dl
Nuclear regulatory protein
Measured: 12 weeks
P38 Mitogen activated protein kinase in nanogram/dl
Transcription regulatory protein
Measured: 12 weeks
Inhibitory Kappa Beta protein in nanogram/dl
inhibitory protein
Measured: 12 weeks
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
Proinflammatory cytokines
Measured: 12 weeks
Plasminogen activated protein inhibitor1 in picogram/dl
Protein Inhibitor
Measured: 12 weeks
Fasting Insulin in nanogram/dl
Metabolic hormone
Measured: 12 weeks
Insulin resistance by HOMA index
Measuring cells sensitivity to insulin
Measured: 12 weeks
Secondary outcomes (2)
Fasting Blood Sugar in mg/dl
Biochemical serological markers
Measured: 12 weeks
Lipid profile in mg/dl
Serological markers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start4 Dec 2019
- Primary completion10 Jan 2021
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome in Postmenopausal FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Postmenopausal females are randomly selected to receive Gum Arabic treatment and intended outcomes will be measured before and after the intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education and Scientific Research, Republic of Sudan
- Responsible party
- Principal investigator, Fatima Elhaj, University of Khartoum
- Investigators
- Fatima Elhaj, PhD, Principal investigator, lecturer in physiology department University of KhartoumShaza Elawad, MSc, Principal investigator, lecturer in physiology department University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978103
- Sponsor's protocol ID
- NMPB/0047815
- Status last verified
- Feb 2026
- First submitted
- 10 Jul 2021
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gum Arabic Supplementation on the Components of Metabolic Syndrome Among Post Menopausal Females in Khartoum State 2019
- ClinicalTrials.gov ID
- NCT04978103
- Acronym / sponsor ID
- NMPB/0047815
- Keywords
- Gum Arabic, Inflammatory markers, Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- Ministry of Higher Education and Scientific Research, Republic of Sudan
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Postmenopausal females are randomly selected to receive Gum Arabic treatment and intended outcomes will be measured before and after the intervention
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Gum ArabicHundred 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 |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum ArabicAlso: Acacia SenegalA dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414)) | Drug | Single Arm |
Primary outcome
Nuclear Factor Kappa Beta concentration in nanogram/dl
Time frame: 12 weeks
Nuclear regulatory protein
P38 Mitogen activated protein kinase in nanogram/dl
Time frame: 12 weeks
Transcription regulatory protein
Inhibitory Kappa Beta protein in nanogram/dl
Time frame: 12 weeks
inhibitory protein
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
Time frame: 12 weeks
Proinflammatory cytokines
Plasminogen activated protein inhibitor1 in picogram/dl
Time frame: 12 weeks
Protein Inhibitor
Fasting Insulin in nanogram/dl
Time frame: 12 weeks
Metabolic hormone
Insulin resistance by HOMA index
Time frame: 12 weeks
Measuring cells sensitivity to insulin
2 secondary outcomes
Fasting Blood Sugar in mg/dl
Time frame: 12 weeks
Lipid profile in mg/dl
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome
Metabolic Syndrome, Overweight
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Hyperbaric Oxygen Therapy on Insulin Resistance in Postmenopause
Insulin Resistance Syndrome
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Physical Activity and Disability Prevention in Postmenopausal Women
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Evaluation of Lifestyle Modification on Cardiovascular Risk
Metabolic Syndrome, Menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Elhaj, PhD principal investigator
lecturer in physiology department University of Khartoum
Shaza Elawad, MSc principal investigator
lecturer in physiology department University of Khartoum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gum Arabic in people with Metabolic Syndrome in Postmenopausal Females, run by University of Khartoum at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nuclear Factor Kappa Beta concentration in nanogram/dl (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.