The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients

Study Overview
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Brief Summary
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Saudi Arabia has the highest prevalence (24%) of type 2 diabetes mellitus (T2DM) among the modern nation states in the world. In addition, majority of Saudi diabetic patient do not have their blood glucose controlled. Data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and HbA1c (glycated hemoglobin). Olive oil has been associated with weight reduction as well as improvements in lipid profile (increase in high density (HDL) and decrease in low-density lipoprotein (LDL)). No randomized controlled trial has specifically examined the effect of olive oil as a supplement on blood glucose among diabetics. The study objective is to test the effect of daily consumption (30 mL) of extra-virgin olive oil (EVOO) on HbA1c among patients with type 2 diabetes.

Detailed Description
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Problem: Saudi Arabia has the highest prevalence (24%) of type 2 diabetes mellitus (T2DM) among the modern nation states in the world. In addition, majority of Saudi diabetic patient do not have their blood glucose controlled. Significance: Data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and HbA1c (glycated hemoglobin). Olive oil has been associated with weight reduction as well as improvements in lipid profile (increase in high density (HDL) and decrease in low-density lipoprotein (LDL)). No randomized controlled trial has specifically examined the effect of olive oil as a supplement on blood glucose among diabetics. Objectives: To test the effect of daily consumption (30 mL) of extra-virgin olive oil (EVOO) on HbA1c among patients with type 2 diabetes. Methods: The study design will be an open-label randomized controlled trial with 2 groups (EVOO versus no oil). The study will include 420 patients and each patient will be followed for 3 months. Group difference in HbA1c will be compared at 3 months to determine the effect of EVOO. Implications: Dietary supplementation of EVOO could aid Saudi diabetic patients in keeping blood glucose levels controlled.

Official Title
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The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients: An Open-label Parallel Group Randomized Controlled Trial.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Extra virgin olive oil (30mL daily)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with Type 2 diabetes within 10 years of enrollment baseline HbA1C > 7%, willing to supplement the diet with oil able to read and write Exclusion Criteria: type 1 diabetes mellitus have gall-bladder or liver diseases or malabsorption or Crohn's disease have advanced heart disease have an aversion or allergy to olive oil already using olive oil daily as a dietary supplement morbidly obese (Body Mass Index >40 kg/m2)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extra virgin olive oil<br>Extra virgin olive oil (30mL) daily | Dietary Supplement: Extra virgin olive oil (30mL daily)<br>* Intervention arm will take 30 mL of Extra virgin olive oil daily.<br>|
| No Intervention: Control<br>No consumption of extra virgin olive oil | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycated hemoglobin) |  | 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose |  | 3-month follow-up | 
| Lipid Profile | High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol | 3-month follow-up | 
| Weight |  | 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose