The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Extra virgin olive oil (30mL daily)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
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)
Sites / Locations
- Buraidah Diabetic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Extra virgin olive oil
Control
Arm Description
Extra virgin olive oil (30mL) daily
No consumption of extra virgin olive oil
Outcomes
Primary Outcome Measures
HbA1c (glycated hemoglobin)
Secondary Outcome Measures
Fasting Plasma Glucose
Lipid Profile
High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol
Weight
Full Information
NCT ID
NCT03447301
First Posted
February 18, 2018
Last Updated
February 25, 2018
Sponsor
Sulaiman AlRajhi Colleges
Collaborators
Qassim University, Ministry of Health, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT03447301
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2018 (Anticipated)
Primary Completion Date
August 25, 2018 (Anticipated)
Study Completion Date
December 25, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sulaiman AlRajhi Colleges
Collaborators
Qassim University, Ministry of Health, Saudi Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extra virgin olive oil
Arm Type
Experimental
Arm Description
Extra virgin olive oil (30mL) daily
Arm Title
Control
Arm Type
No Intervention
Arm Description
No consumption of extra virgin olive oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Extra virgin olive oil (30mL daily)
Intervention Description
Intervention arm will take 30 mL of Extra virgin olive oil daily.
Primary Outcome Measure Information:
Title
HbA1c (glycated hemoglobin)
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose
Time Frame
3-month follow-up
Title
Lipid Profile
Description
High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol
Time Frame
3-month follow-up
Title
Weight
Time Frame
3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazmus Saquib, PhD
Phone
966 0533445899
Email
a.saquib@sr.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Juliann Saquib, PhD
Phone
966 507136832
Email
juliannsaquib@qumed.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazmus Saquib, PhD
Organizational Affiliation
Sulaiman Al-Rajhi Colleges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buraidah Diabetic Center
City
Buraidah
State/Province
Al-Qassim
ZIP/Postal Code
52366
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saddik Zaghoul, MBBS
Email
mohamed_saddik@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
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