NCT03447301

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Sulaiman AlRajhi Colleges · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Extra virgin olive oil (30mL daily)	Intervention arm will take 30 mL of Extra virgin olive oil daily.

Timeline

• Start date: 2018-02-25
• Primary completion: 2018-08-25
• Completion: 2018-12-25
• First posted: 2018-02-27
• Last updated: 2018-02-27

Locations

1 site across 1 country: Saudi Arabia