Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Qassim University
Ministry of Health, Saudi Arabia
Information provided by (Responsible Party):
Sulaiman AlRajhi Colleges

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Extra virgin olive oil (30mL daily) Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Olive oil

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HbA1c (glycated hemoglobin) [ Time Frame: 3-month follow-up ]

Secondary Outcome Measures :
  1. Fasting Plasma Glucose [ Time Frame: 3-month follow-up ]
  2. Lipid Profile [ Time Frame: 3-month follow-up ]
    High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol

  3. Weight [ Time Frame: 3-month follow-up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Nazmus Saquib, PhD 966 0533445899 a.saquib@sr.edu.sa
Contact: Juliann Saquib, PhD 966 507136832 juliannsaquib@qumed.edu.sa

Locations
Layout table for location information
Saudi Arabia
Buraidah Diabetic Center
Buraidah, Al-Qassim, Saudi Arabia, 52366
Contact: Saddik Zaghoul, MBBS       mohamed_saddik@hotmail.com   
Sponsors and Collaborators
Sulaiman AlRajhi Colleges
Qassim University
Ministry of Health, Saudi Arabia
Investigators
Layout table for investigator information
Principal Investigator: Nazmus Saquib, PhD Sulaiman Al-Rajhi Colleges
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sulaiman AlRajhi Colleges
ClinicalTrials.gov Identifier: NCT03447301    
Other Study ID Numbers: SulaimanAC
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sulaiman AlRajhi Colleges:
Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases