Trial | NCT03447301  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
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.
Study Started
Feb 25
2018
Anticipated
Primary Completion
Aug 25
2018
Anticipated
Study Completion
Dec 25
2018
Anticipated
Last Update
Feb 27
2018

Dietary Supplement Extra virgin olive oil (30mL daily)

Intervention arm will take 30 mL of Extra virgin olive oil daily.

Extra virgin olive oil Experimental

Extra virgin olive oil (30mL) daily

Control No Intervention

No consumption of extra virgin olive oil

Criteria 

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)
No Results Posted