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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891927
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Aml Ali Aboelghait, Assiut University

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: extra virgin olive oil Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinicl trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion in Patients With Type 2 Diabetes
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Experimental: olive group
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)
Dietary Supplement: extra virgin olive oil
During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO

No Intervention: non olive group
No intervention



Primary Outcome Measures :
  1. change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil [ Time Frame: 3 months ]

    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.


  2. change of fasting glucose after intervention by extra virgin olive oil [ Time Frame: 3 months ]

    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 :
  1. calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil [ Time Frame: 3 months. ]

    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


  2. reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil . [ Time Frame: 3 months ]
    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

  3. reduction of body mass index . [ Time Frame: 3 months ]
    height , weight measuring and calculating BMI.Body mass index (BMI) was calculated as weight (kg) divided by squared height (m).

  4. changing in waist circumference . [ Time Frame: 3 months follow up ]
    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

  5. change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention . [ Time Frame: 3 months follow up ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891927


Contacts
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Contact: Aml Ali Aboelghait, MD 01021191660 ext 002 amlaliaboelghait98@yahoo.com
Contact: safaa AA Khaled, MD 01064170058 ext 002 safaakhaled2003@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Salah Abdelazeem Argoon, professor Assiut University
Publications:
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Responsible Party: Aml Ali Aboelghait, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03891927    
Other Study ID Numbers: olive oil on glycemic control
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aml Ali Aboelghait, Assiut University:
olive oil
glycemic control
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases