Clinical trial NCT04978103: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metabolic Syndrome in Postmenopausal Females
Keywords: Gum Arabic
Inflammatory markers
Metabolic Syndrome
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: Ministry of Higher Education and Scientific Research, Republic of Sudan
First posted: 2021-07-27
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Postmenopausal females are randomly selected to receive Gum Arabic treatment and intended outcomes will be measured before and after the intervention
Primary purpose: TREATMENT

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.

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

  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.

Primary outcomes:
measure: Nuclear Factor Kappa Beta concentration in nanogram/dl
timeFrame: 12 weeks
measure: P38 Mitogen activated protein kinase in nanogram/dl
timeFrame: 12 weeks
measure: Inhibitory Kappa Beta protein in nanogram/dl
timeFrame: 12 weeks
measure: Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl
timeFrame: 12 weeks
measure: Plasminogen activated protein inhibitor1 in picogram/dl
timeFrame: 12 weeks
measure: Fasting Insulin in nanogram/dl
timeFrame: 12 weeks
measure: Insulin resistance by HOMA index
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting Blood Sugar in mg/dl
timeFrame: 12 weeks
measure: Lipid profile in mg/dl
timeFrame: 12 weeks
Other outcomes:
measure: waist circumference in cm
timeFrame: 12 weeks
Locations:
city: Khartoum
country: Sudan
facility: University of Khartoum
Study officials:
affiliation: lecturer in physiology department University of Khartoum
name: Fatima Elhaj, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer in physiology department University of Khartoum
name: Shaza Elawad, MSc
role: PRINCIPAL_INVESTIGATOR
References: