Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03891927
Status:
UNKNOWN
Last Update Posted:
2019-04-01
First Post:
2019-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinicl trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil', 'timeFrame': '3 months', 'description': 'change of HBa1c (glycated hemoglobin) after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil) to evaluate glycemic control .\n\nmeasurment of HBa1c for group of intervention at baseline and after 3 months intervention .\n\nand other group (no intervention of olive oil) at baseline and after 3 months.'}, {'measure': 'change of fasting glucose after intervention by extra virgin olive oil', 'timeFrame': '3 months', 'description': 'change of fasting glucose after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil) to evaluate glycemic control .\n\nmeasurment of fasting glucose for group of intervention at baseline and after 3 months intervention .\n\nand other group (no intervention of olive oil) at baseline and after 3 months.'}], 'secondaryOutcomes': [{'measure': 'calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil', 'timeFrame': '3 months.', 'description': 'measurement of fasting insulin after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil) to evaluate insulin resistance and insulin secretion by calculating HOMA -IR and HOMA-B The HOMA-beta cell function (HOMA-B) will be calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).\n\n(HOMA-IR) method: fasting glucose (mg/dl) x fasting insulin / 405'}, {'measure': 'reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .', 'timeFrame': '3 months', 'description': 'measurement of systolic and diastolic blood pressure after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group'}, {'measure': 'reduction of body mass index .', 'timeFrame': '3 months', 'description': 'height , weight measuring and calculating BMI.Body mass index (BMI) was calculated as weight (kg) divided by squared height (m).'}, {'measure': 'changing in waist circumference .', 'timeFrame': '3 months follow up', 'description': 'waist circumference change will be measured by tape measure at the umbilical level while patients standing after expiration by centimeter after intervention by 30 ml extra virgin olive oil daily for three months'}, {'measure': 'change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .', 'timeFrame': '3 months follow up', 'description': 'change at Lipid profile (cholesterol, TG, LDL, HDL) (cholesterol by mg/dl ,triglyceride by mg/dl ,low density lipoprotein by mg/dl and high density lipoprotein by mg/dl ) after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['olive oil', 'glycemic control'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '28394365', 'type': 'BACKGROUND', 'citation': 'Schwingshackl L, Lampousi AM, Portillo MP, Romaguera D, Hoffmann G, Boeing H. Olive oil in the prevention and management of type 2 diabetes mellitus: a systematic review and meta-analysis of cohort studies and intervention trials. Nutr Diabetes. 2017 Apr 10;7(4):e262. doi: 10.1038/nutd.2017.12.'}, {'pmid': '27344308', 'type': 'BACKGROUND', 'citation': "Santangelo C, Filesi C, Vari R, Scazzocchio B, Filardi T, Fogliano V, D'Archivio M, Giovannini C, Lenzi A, Morano S, Masella R. Consumption of extra-virgin olive oil rich in phenolic compounds improves metabolic control in patients with type 2 diabetes mellitus: a possible involvement of reduced levels of circulating visfatin. J Endocrinol Invest. 2016 Nov;39(11):1295-1301. doi: 10.1007/s40618-016-0506-9. Epub 2016 Jun 25."}, {'pmid': '24625239', 'type': 'BACKGROUND', 'citation': 'Nigam P, Bhatt S, Misra A, Chadha DS, Vaidya M, Dasgupta J, Pasha QM. Effect of a 6-month intervention with cooking oils containing a high concentration of monounsaturated fatty acids (olive and canola oils) compared with control oil in male Asian Indians with nonalcoholic fatty liver disease. Diabetes Technol Ther. 2014 Apr;16(4):255-61. doi: 10.1089/dia.2013.0178.'}, {'pmid': '27794174', 'type': 'BACKGROUND', 'citation': 'Lama A, Pirozzi C, Mollica MP, Trinchese G, Di Guida F, Cavaliere G, Calignano A, Mattace Raso G, Berni Canani R, Meli R. Polyphenol-rich virgin olive oil reduces insulin resistance and liver inflammation and improves mitochondrial dysfunction in high-fat diet fed rats. Mol Nutr Food Res. 2017 Mar;61(3). doi: 10.1002/mnfr.201600418. Epub 2016 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this study to evaluate the effects of extra virgin olive oil on glycemic control ,insulin resistance and insulin secretion in patients with Type 2 diabetics.', 'detailedDescription': 'Diabetes is a major health problem and one of the leading causes of morbidity and mortality worldwide. Lifestyle and particularly dietary habits are considered key issues in both the prevention and management of the disease aimed at achieving an adequate glycemic control or at delaying the onset of diabetic chronic complications .\n\nOlive oil (OO) has been recognized for centuries for its nutritional properties and considered as the "elixir of youth and health" by antique Greeks. Extra virgin olive oil is the main source of dietary fat in the Mediterranean diet . Consumption of extra virgin olive oil might exert beneficial effects in the prevention, development and progression of T2D compared with refined olive oil .\n\nSeveral bioactive ingredients within OO have been repeatedly linked with anti-oxidant and anti-inflammatory preventative functions, particularly those from monounsaturated fatty acids (MUFA), and key biophenols such as oleuropein and hydroxytyrosol (HT) . Biophenols may influence glucose metabolism via several mechanisms; inhibition of carbohydrate digestion and glucose absorption in the intestine, activation of insulin receptors and glucose uptake in the tissues, antioxidative properties, potent free-radical scavenging and immunomodulatory effects. Multiple studies proven that EVOO improve metabolic control by affection of adipokines .The inhibition of carbohydrate digestion and absorption takes place through an inhibition of some digestive enzymes, especially the carbohydrate-hydrolyzing enzymes α-amylase and α glucosidase. Inhibition of these enzymes retards carbohydrate digestion, thus causing a reduction in glucose absorption rate .With their antioxidative properties, polyphenols diminish the production of advanced glycosylated end products such as HbA1c, AGEs, which are readily formed and accumulated with sustained hyperglycemia, contribute to the development of diabetic complications. As a consequence, inhibition of AGE formation constitutes an attractive therapeutic/preventive target .\n\nStudies both in healthy subjects and in persons with type 2 diabetes mellitus have demonstrated that levels of GLP-1are increased more by dietary MUFA than by dietary saturated fatty acids, and that the greater postprandial clearance of an oral overload of MUFA-rich fats is associated with a greater increase in postprandial incretins such as GLP-1 or gastric inhibitory polypeptide. MUFAs from olive oil, therefore, appear to significantly increase the insulin and GPL-1 secretion .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with type 2 diabetes with\n\n* age 30-60 years regardless of their gender.\n* Duration of diabetes less than 5 years.\n* on oral antihyperglycemic medication.\n* willing to participate in research.\n\nExclusion Criteria:\n\n* Type 1 diabetes.\n* Insulin treated type 2 DM patients.\n* Pregnant women .\n* Patients on cholesterol-lowering drugs, steroids and other drugs that affect the fat metabolism.\n* Patients on regular (days) supplement that contain olive oil.\n* Patients have aversion or allergy to olive oil.\n* Smokers .\n* Patients have gall bladder disease ,gastrointestinal disease (e.g.malabsorption),liver,kidney,heart and thyroid diseases.'}, 'identificationModule': {'nctId': 'NCT03891927', 'briefTitle': 'Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'olive oil on glycemic control'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'olive group', 'description': 'During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO ( high polypheol Extra virgin olive oil)', 'interventionNames': ['Dietary Supplement: extra virgin olive oil']}, {'type': 'NO_INTERVENTION', 'label': 'non olive group', 'description': 'No intervention'}], 'interventions': [{'name': 'extra virgin olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO', 'armGroupLabels': ['olive group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aml Ali Aboelghait, MD', 'role': 'CONTACT', 'email': 'amlaliaboelghait98@yahoo.com', 'phone': '01021191660', 'phoneExt': '002'}, {'name': 'safaa AA Khaled, MD', 'role': 'CONTACT', 'email': 'safaakhaled2003@gmail.com', 'phone': '01064170058', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Salah Abdelazeem Argoon, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Aml Ali Aboelghait', 'investigatorAffiliation': 'Assiut University'}}}}