An interventional study of Extra virgin olive oil (30mL daily) in Type 2 Diabetes Mellitus, sponsored by Sulaiman AlRajhi Colleges. Status unknown at 1 site in Saudi Arabia. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-27.
Sponsored by Sulaiman AlRajhi Colleges · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Extra virgin olive oil (30mL) daily
Dietary Supplement: Extra virgin olive oil (30mL daily)
No consumption of extra virgin olive oil
Intervention arm will take 30 mL of Extra virgin olive oil daily.
HbA1c (glycated hemoglobin)
Time frame: 3-month follow-up
Fasting Plasma Glucose
Time frame: 3-month follow-up
Lipid Profile
High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol
Time frame: 3-month follow-up
Weight
Time frame: 3-month follow-up
Plan to share: No
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Sulaiman AlRajhi Colleges