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Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion

Primary Purpose

Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
extra virgin olive oil
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring olive oil, glycemic control

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with type 2 diabetes with

  • age 30-60 years regardless of their gender.
  • Duration of diabetes less than 5 years.
  • on oral antihyperglycemic medication.
  • willing to participate in research.

Exclusion Criteria:

  • Type 1 diabetes.
  • Insulin treated type 2 DM patients.
  • Pregnant women .
  • Patients on cholesterol-lowering drugs, steroids and other drugs that affect the fat metabolism.
  • Patients on regular (days) supplement that contain olive oil.
  • Patients have aversion or allergy to olive oil.
  • Smokers .
  • Patients have gall bladder disease ,gastrointestinal disease (e.g.malabsorption),liver,kidney,heart and thyroid diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    olive group

    non olive group

    Arm 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)

    No intervention

    Outcomes

    Primary Outcome Measures

    change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil
    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 . measurment of HBa1c for group of intervention at baseline and after 3 months intervention . and other group (no intervention of olive oil) at baseline and after 3 months.
    change of fasting glucose after intervention by extra virgin olive oil
    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 . measurment of fasting glucose for group of intervention at baseline and after 3 months intervention . and other group (no intervention of olive oil) at baseline and after 3 months.

    Secondary Outcome Measures

    calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil
    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). (HOMA-IR) method: fasting glucose (mg/dl) x fasting insulin / 405
    reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .
    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
    reduction of body mass index .
    height , weight measuring and calculating BMI.Body mass index (BMI) was calculated as weight (kg) divided by squared height (m).
    changing in waist circumference .
    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
    change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .
    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)

    Full Information

    First Posted
    March 18, 2019
    Last Updated
    March 29, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03891927
    Brief Title
    Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion
    Official Title
    Effect of Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion in Patients With Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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 . Olive 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 . Several 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 . Studies 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance
    Keywords
    olive oil, glycemic control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized clinicl trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    olive group
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    non olive group
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    extra virgin olive oil
    Intervention Description
    During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO
    Primary Outcome Measure Information:
    Title
    change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil
    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 . measurment of HBa1c for group of intervention at baseline and after 3 months intervention . and other group (no intervention of olive oil) at baseline and after 3 months.
    Time Frame
    3 months
    Title
    change of fasting glucose after intervention by extra virgin olive oil
    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 . measurment of fasting glucose for group of intervention at baseline and after 3 months intervention . and other group (no intervention of olive oil) at baseline and after 3 months.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil
    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). (HOMA-IR) method: fasting glucose (mg/dl) x fasting insulin / 405
    Time Frame
    3 months.
    Title
    reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .
    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
    Time Frame
    3 months
    Title
    reduction of body mass index .
    Description
    height , weight measuring and calculating BMI.Body mass index (BMI) was calculated as weight (kg) divided by squared height (m).
    Time Frame
    3 months
    Title
    changing in waist circumference .
    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
    Time Frame
    3 months follow up
    Title
    change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .
    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)
    Time Frame
    3 months follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Patients with type 2 diabetes with age 30-60 years regardless of their gender. Duration of diabetes less than 5 years. on oral antihyperglycemic medication. willing to participate in research. Exclusion Criteria: Type 1 diabetes. Insulin treated type 2 DM patients. Pregnant women . Patients on cholesterol-lowering drugs, steroids and other drugs that affect the fat metabolism. Patients on regular (days) supplement that contain olive oil. Patients have aversion or allergy to olive oil. Smokers . Patients have gall bladder disease ,gastrointestinal disease (e.g.malabsorption),liver,kidney,heart and thyroid diseases.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aml Ali Aboelghait, MD
    Phone
    01021191660
    Ext
    002
    Email
    amlaliaboelghait98@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    safaa AA Khaled, MD
    Phone
    01064170058
    Ext
    002
    Email
    safaakhaled2003@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salah Abdelazeem Argoon, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28394365
    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.
    Results Reference
    background
    PubMed Identifier
    27344308
    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.
    Results Reference
    background
    PubMed Identifier
    24625239
    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.
    Results Reference
    background
    PubMed Identifier
    27794174
    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.
    Results Reference
    background

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    Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion

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