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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Extra virgin olive oil (30mL daily)

• Registration Number: NCT03447301
• Lead Sponsor: Sulaiman AlRajhi Colleges

Brief 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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-18
• Study Start: 2018-02-25
• Study First Submitted QC: 2018-02-25
• Last Update Submitted: 2018-02-25
• Study First Posted: 2018-02-27
• Last Update Posted: 2018-02-27
• Primary Completion: 2018-08-25
• Study Completion: 2018-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra virgin olive oil	Extra virgin olive oil (30mL daily)	Extra virgin olive oil (30mL) daily

Primary Outcome Measures

Name	Time	Method
HbA1c (glycated hemoglobin)	3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose	3-month follow-up
Lipid Profile	3-month follow-up	High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol
Weight	3-month follow-up

Trial Locations

Locations (1)

Buraidah Diabetic Center; 🇸🇦 Buraidah, Al-Qassim, Saudi Arabia