Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-19 @ 5:05 AM
Study NCT ID:
NCT04978103
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006170', 'term': 'Gum Arabic'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Both the investigators and outcome assessors will be given codes of the participants for further analysis'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Postmenopausal females are randomly selected to receive Gum Arabic treatment and intended outcomes will be measured before and after the intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2021-07-10', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'waist circumference in cm', 'timeFrame': '12 weeks', 'description': 'Anthropometric measurement'}], 'primaryOutcomes': [{'measure': 'Nuclear Factor Kappa Beta concentration in nanogram/dl', 'timeFrame': '12 weeks', 'description': 'Nuclear regulatory protein'}, {'measure': 'P38 Mitogen activated protein kinase in nanogram/dl', 'timeFrame': '12 weeks', 'description': 'Transcription regulatory protein'}, {'measure': 'Inhibitory Kappa Beta protein in nanogram/dl', 'timeFrame': '12 weeks', 'description': 'inhibitory protein'}, {'measure': 'Tumor necrosis factor, interferon gamma and interleukin-6 in nanogram/dl', 'timeFrame': '12 weeks', 'description': 'Proinflammatory cytokines'}, {'measure': 'Plasminogen activated protein inhibitor1 in picogram/dl', 'timeFrame': '12 weeks', 'description': 'Protein Inhibitor'}, {'measure': 'Fasting Insulin in nanogram/dl', 'timeFrame': '12 weeks', 'description': 'Metabolic hormone'}, {'measure': 'Insulin resistance by HOMA index', 'timeFrame': '12 weeks', 'description': 'Measuring cells sensitivity to insulin'}], 'secondaryOutcomes': [{'measure': 'Fasting Blood Sugar in mg/dl', 'timeFrame': '12 weeks', 'description': 'Biochemical serological markers'}, {'measure': 'Lipid profile in mg/dl', 'timeFrame': '12 weeks', 'description': 'Serological markers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gum Arabic', 'Inflammatory markers', 'Metabolic Syndrome'], 'conditions': ['Metabolic Syndrome in Postmenopausal Females']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHypertension, 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.\n\nGum 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.\n\nButyrate treatment was found to inhibit expression of cytokine mRNAs in peripheral blood monocytes (PBMC) that are stimulated by bacterial lipopolysaccharide (LPS).\n\nIn 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).\n\nWhen 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.\n\nThis 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.\n\nConsequently; the postulated mechanisms by which butyrate may regulate gene expression are through inhibition of NFκB activation and IκBα degradation.\n\nNFκB and the inflammatory cytokines: Target for therapy in inflammatory diseases, are they?\n\nAs 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.\n\nThe anti-inflammatory and immune-modulatory properties of gum Arabic, through butyrate, described previously may offer an interesting alternative therapeutic approach for inflammatory conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'postmenopausal females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria Females Menopause Metabolic syndrome based on Adult panel II criteria Signed/verbal consent to participate\n\nExclusion Criteria:\n\n* Exclusion criteria\n\n 1. Patients with mental or physical disability\n 2. Use of corticosteroids or any other drug that affects body weight\n 3. History of Gum Arabic (GA) allergy\n 4. Chronicrenal or liver disease\n 5. Chronocinflammatory diseases\n 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.'}, 'identificationModule': {'nctId': 'NCT04978103', 'briefTitle': 'Effects of Gum Arabic on Metabolic Syndrome Parameters in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Khartoum'}, 'officialTitle': 'Effects of Gum Arabic Supplementation on the Components of Metabolic Syndrome Among Post Menopausal Females in Khartoum State 2019', 'orgStudyIdInfo': {'id': 'NMPB/0047815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single 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', 'interventionNames': ['Drug: Gum Arabic']}], 'interventions': [{'name': 'Gum Arabic', 'type': 'DRUG', 'otherNames': ['Acacia Senegal'], 'description': 'A dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414))', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Khartoum', 'country': 'Sudan', 'facility': 'University of Khartoum', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}], 'overallOfficials': [{'name': 'Fatima Elhaj, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer in physiology department University of Khartoum'}, {'name': 'Shaza Elawad, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer in physiology department University of Khartoum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Khartoum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Higher Education and Scientific Research, Republic of Sudan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatima Elhaj', 'investigatorAffiliation': 'University of Khartoum'}}}}