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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
Sponsor:
Collaborators:
Qassim University
Ministry of Health, Saudi Arabia
Information provided by (Responsible Party):
Sulaiman AlRajhi Colleges

Tracking Information
First Submitted Date  ICMJE February 18, 2018
First Posted Date  ICMJE February 27, 2018
Last Update Posted Date February 27, 2018
Estimated Study Start Date  ICMJE February 25, 2018
Estimated Primary Completion Date August 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2018)
HbA1c (glycated hemoglobin) [ Time Frame: 3-month follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
Official Title  ICMJE The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients: An Open-label Parallel Group Randomized Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE Dietary Supplement: Extra virgin olive oil (30mL daily)
Intervention arm will take 30 mL of Extra virgin olive oil daily.
Study Arms  ICMJE
  • Experimental: Extra virgin olive oil
    Extra virgin olive oil (30mL) daily
    Intervention: Dietary Supplement: Extra virgin olive oil (30mL daily)
  • No Intervention: Control
    No consumption of extra virgin olive oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 25, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 25, 2018
Estimated Primary Completion Date August 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03447301
Other Study ID Numbers  ICMJE SulaimanAC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sulaiman AlRajhi Colleges
Study Sponsor  ICMJE Sulaiman AlRajhi Colleges
Collaborators  ICMJE
  • Qassim University
  • Ministry of Health, Saudi Arabia
Investigators  ICMJE
Principal Investigator: Nazmus Saquib, PhD Sulaiman Al-Rajhi Colleges
PRS Account Sulaiman AlRajhi Colleges
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP