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

March 29, 2019 updated by: Aml Ali Aboelghait, Assiut University

Effect of Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion in Patients With Type 2 Diabetes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months.
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 months
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).
3 months
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
3 months follow up
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)
3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Salah Abdelazeem Argoon, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • olive oil on glycemic control

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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