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

Sulaiman AlRajhi Colleges

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Extra virgin olive oil (30mL daily)

Study type: Interventional

Funder types: Other

Identifiers

NCT03447301

SulaimanAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Extra virgin olive oil

Experimental group

Description:

Extra virgin olive oil (30mL) daily

Treatment:

Dietary Supplement: Extra virgin olive oil (30mL daily)

Control

No Intervention group

Description:

No consumption of extra virgin olive oil