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

• ClinicalTrials.gov Identifier: NCT03447301
• Recruitment Status: Unknown
• First Posted: February 27, 2018
• Last Update Posted: February 27, 2018
• Sponsor: Sulaiman AlRajhi Colleges
• Collaborators: Qassim University; Ministry of Health, Saudi Arabia
• Information provided by (Responsible Party): Sulaiman AlRajhi Colleges

Tracking Information

• First Submitted Date: February 18, 2018
• First Posted Date: February 27, 2018
• Last Update Posted Date: February 27, 2018
• Estimated Study Start Date: February 25, 2018
• Estimated Primary Completion Date: August 25, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 25, 2018): HbA1c (glycated hemoglobin) [ Time Frame: 3-month follow-up ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

Dietary Supplement: Extra virgin olive oil (30mL daily)

Intervention arm will take 30 mL of Extra virgin olive oil daily.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 25, 2018): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 25, 2018
• Estimated Primary Completion Date: August 25, 2018 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Saudi Arabia

Administrative Information

• NCT Number: NCT03447301
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Sulaiman AlRajhi Colleges
• Original Responsible Party: Same as current
• Current Study Sponsor: Sulaiman AlRajhi Colleges
• Original Study Sponsor: Same as current

Collaborators

• Qassim University
• Ministry of Health, Saudi Arabia

Investigators

• Principal Investigator: Nazmus Saquib, PhD; Sulaiman Al-Rajhi Colleges

• PRS Account: Sulaiman AlRajhi Colleges
• Verification Date: February 2018