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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03447301
• Other study ID #: SulaimanAC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2018
• Last updated: February 25, 2018
• Start date: February 25, 2018
• Est. completion date: December 25, 2018

Study information

• Verified date: February 2018
• Source: Sulaiman AlRajhi Colleges
• Contact: Nazmus Saquib, PhD
• Phone: 966 0533445899
• Email: a.saquib[@]sr.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 25, 2018
• Est. primary completion date: August 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Extra virgin olive oil (30mL daily)
Intervention arm will take 30 mL of Extra virgin olive oil daily.

Locations

Country	Name	City	State
Saudi Arabia	Buraidah Diabetic Center	Buraidah	Al-Qassim

Sponsors (3)

Lead Sponsor	Collaborator
Sulaiman AlRajhi Colleges	Ministry of Health, Saudi Arabia, Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c (glycated hemoglobin)		3-month follow-up
Secondary	Fasting Plasma Glucose		3-month follow-up
Secondary	Lipid Profile	High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol	3-month follow-up
Secondary	Weight		3-month follow-up