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.

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Extra virgin olive oil (30mL daily)

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al-Qassim
    • Buraidah, Al-Qassim, Saudi Arabia, 52366
      • Buraidah Diabetic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extra virgin olive oil; Extra virgin olive oil (30mL) daily	Dietary supplement: Extra virgin olive oil (30mL daily); Intervention arm will take 30 mL of Extra virgin olive oil daily.
No Intervention: Control; No consumption of extra virgin olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c (glycated hemoglobin)	3-month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sulaiman AlRajhi Colleges
• Collaborators: Ministry of Health, Saudi Arabia; Qassim University
• Investigators: Principal Investigator: Nazmus Saquib, PhD, Sulaiman Al-Rajhi Colleges

Study record dates

Study Major Dates

• Study Start (Anticipated): February 25, 2018
• Primary Completion (Anticipated): August 25, 2018
• Study Completion (Anticipated): December 25, 2018

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SulaimanAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No