The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
NCT ID: NCT03447301
Last Updated: 2018-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-02-25
2018-12-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Extra virgin olive oil
Extra virgin olive oil (30mL) daily
Extra virgin olive oil (30mL daily)
Intervention arm will take 30 mL of Extra virgin olive oil daily.
Control
No consumption of extra virgin olive oil
No interventions assigned to this group
Interventions
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Extra virgin olive oil (30mL daily)
Intervention arm will take 30 mL of Extra virgin olive oil daily.
Eligibility Criteria
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Inclusion Criteria
* baseline HbA1C \> 7%,
* willing to supplement the diet with oil
* able to read and write
Exclusion Criteria
* 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)
20 Years
60 Years
ALL
No
Sponsors
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Qassim University
OTHER
Ministry of Health, Saudi Arabia
OTHER_GOV
Sulaiman AlRajhi Colleges
OTHER
Responsible Party
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Principal Investigators
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Nazmus Saquib, PhD
Role: PRINCIPAL_INVESTIGATOR
Sulaiman Al-Rajhi Colleges
Locations
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Buraidah Diabetic Center
Buraidah, Al-Qassim, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SulaimanAC
Identifier Type: -
Identifier Source: org_study_id
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