The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT03447301|
Recruitment Status : Unknown
Verified February 2018 by Sulaiman AlRajhi Colleges.
Recruitment status was: Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Dietary Supplement: Extra virgin olive oil (30mL daily)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||February 25, 2018|
|Estimated Primary Completion Date :||August 25, 2018|
|Estimated Study Completion Date :||December 25, 2018|
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
- HbA1c (glycated hemoglobin) [ Time Frame: 3-month follow-up ]
- Fasting Plasma Glucose [ Time Frame: 3-month follow-up ]
- Lipid Profile [ Time Frame: 3-month follow-up ]High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol
- Weight [ Time Frame: 3-month follow-up ]
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|Ages Eligible for Study:||20 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447301
|Contact: Nazmus Saquib, PhD||966 firstname.lastname@example.org|
|Contact: Juliann Saquib, PhD||966 email@example.com|
|Buraidah Diabetic Center|
|Buraidah, Al-Qassim, Saudi Arabia, 52366|
|Contact: Saddik Zaghoul, MBBS firstname.lastname@example.org|
|Principal Investigator:||Nazmus Saquib, PhD||Sulaiman Al-Rajhi Colleges|
|Responsible Party:||Sulaiman AlRajhi Colleges|
|Other Study ID Numbers:||
|First Posted:||February 27, 2018 Key Record Dates|
|Last Update Posted:||February 27, 2018|
|Last Verified:||February 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases