Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women
Primary Purpose
Metabolic Syndrome in Postmenopausal Females
Status
Unknown status
Phase
Phase 2
Locations
Sudan
Study Type
Interventional
Intervention
Gum Arabic
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome in Postmenopausal Females focused on measuring Gum Arabic, Inflammatory markers, Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate
Exclusion Criteria:
Exclusion criteria
- 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.
Sites / Locations
- University of Khartoum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
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
Outcomes
Primary Outcome Measures
Nuclear Factor Kappa Beta concentration in nanogram/dl
Nuclear regulatory protein
P38 Mitogen activated protein kinase in nanogram/dl
Transcription regulatory protein
Inhibitory Kappa Beta protein in nanogram/dl
inhibitory protein
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
Proinflammatory cytokines
Plasminogen activated protein inhibitor1 in picogram/dl
Protein Inhibitor
Fasting Insulin in nanogram/dl
Metabolic hormone
Insulin resistance by HOMA index
Measuring cells sensitivity to insulin
Secondary Outcome Measures
Fasting Blood Sugar in mg/dl
Biochemical serological markers
Lipid profile in mg/dl
Serological markers
Full Information
NCT ID
NCT04978103
First Posted
July 10, 2021
Last Updated
July 27, 2021
Sponsor
University of Khartoum
Collaborators
Ministry of Higher Education and Scientific Research, Republic of Sudan
1. Study Identification
Unique Protocol Identification Number
NCT04978103
Brief Title
Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women
Official Title
Effects of Gum Arabic Supplementation on the Components of Metabolic Syndrome Among Post Menopausal Females in Khartoum State 2019
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
Collaborators
Ministry of Higher Education and Scientific Research, Republic of Sudan
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome in Postmenopausal Females
Keywords
Gum Arabic, Inflammatory markers, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Masking Description
Both the investigators and outcome assessors will be given codes of the participants for further analysis
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gum Arabic
Other Intervention Name(s)
Acacia Senegal
Intervention Description
A dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414))
Primary Outcome Measure Information:
Title
Nuclear Factor Kappa Beta concentration in nanogram/dl
Description
Nuclear regulatory protein
Time Frame
12 weeks
Title
P38 Mitogen activated protein kinase in nanogram/dl
Description
Transcription regulatory protein
Time Frame
12 weeks
Title
Inhibitory Kappa Beta protein in nanogram/dl
Description
inhibitory protein
Time Frame
12 weeks
Title
Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
Description
Proinflammatory cytokines
Time Frame
12 weeks
Title
Plasminogen activated protein inhibitor1 in picogram/dl
Description
Protein Inhibitor
Time Frame
12 weeks
Title
Fasting Insulin in nanogram/dl
Description
Metabolic hormone
Time Frame
12 weeks
Title
Insulin resistance by HOMA index
Description
Measuring cells sensitivity to insulin
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting Blood Sugar in mg/dl
Description
Biochemical serological markers
Time Frame
12 weeks
Title
Lipid profile in mg/dl
Description
Serological markers
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
waist circumference in cm
Description
Anthropometric measurement
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
postmenopausal females
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate
Exclusion Criteria:
Exclusion criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Elhaj, Msc
Organizational Affiliation
lecturer in physiology department University of Khartoum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shaza Elawad, MSc
Organizational Affiliation
lecturer in physiology department University of Khartoum
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Khartoum
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan
12. IPD Sharing Statement
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Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women
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