Type 2 Diabetes Mellitus
Conditions
Keywords
Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
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.
Interventions
DIETARY_SUPPLEMENTExtra virgin olive oil (30mL daily)
Intervention arm will take 30 mL of Extra virgin olive oil daily.
Sponsors
Qassim University
Ministry of Health, Saudi Arabia
Sulaiman AlRajhi Colleges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (glycated hemoglobin) | 3-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma Glucose | 3-month follow-up | — |
| Lipid Profile | 3-month follow-up | High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol |
| Weight | 3-month follow-up | — |
Countries
Saudi Arabia
Contacts
Primary ContactNazmus Saquib, PhD
Backup ContactJuliann Saquib, PhD
Outcome results
None listed