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| Name | Class |
|---|---|
| Qassim University | OTHER |
| Ministry of Health, Saudi Arabia | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extra virgin olive oil | Experimental | Extra virgin olive oil (30mL) daily |
|
| Control | No Intervention | No consumption of extra virgin olive oil |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra virgin olive oil (30mL daily) | Dietary Supplement | Intervention arm will take 30 mL of Extra virgin olive oil daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycated hemoglobin) | 3-month follow-up |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nazmus Saquib, PhD | Contact | 966 0533445899 | a.saquib@sr.edu.sa | |
| Juliann Saquib, PhD | Contact | 966 507136832 | juliannsaquib@qumed.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Nazmus Saquib, PhD | Sulaiman Al-Rajhi Colleges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buraidah Diabetic Center | Buraidah | Al-Qassim | 52366 | Saudi Arabia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Weight | 3-month follow-up |
| D004700 | Endocrine System Diseases |