Clinical trial NCT03447301: The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
Lead sponsor: Sulaiman AlRajhi Colleges
Sponsor class: OTHER
Collaborators: name: Qassim University
name: Ministry of Health, Saudi Arabia
First posted: 2018-02-27
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: HbA1c (glycated hemoglobin)
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Fasting Plasma Glucose
timeFrame: 3-month follow-up
measure: Lipid Profile
timeFrame: 3-month follow-up
measure: Weight
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Buraidah Diabetic Center
state: Al-Qassim
Study officials:
affiliation: Sulaiman Al-Rajhi Colleges
name: Nazmus Saquib, PhD
role: PRINCIPAL_INVESTIGATOR
References: