Type 2 Diabetes Mellitus Clinical Trial
Official title:
The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients: An Open-label Parallel Group Randomized Controlled Trial.
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.
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.
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