The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Feb 2018
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2018
CompletedStudy Start
First participant enrolled
February 25, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2018
CompletedFebruary 27, 2018
February 1, 2018
6 months
February 18, 2018
February 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c (glycated hemoglobin)
3-month follow-up
Secondary Outcomes (3)
Fasting Plasma Glucose
3-month follow-up
Lipid Profile
3-month follow-up
Weight
3-month follow-up
Study Arms (2)
Extra virgin olive oil
EXPERIMENTALExtra virgin olive oil (30mL) daily
Control
NO INTERVENTIONNo consumption of extra virgin olive oil
Interventions
Intervention arm will take 30 mL of Extra virgin olive oil daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sulaiman AlRajhi Collegeslead
- Qassim Universitycollaborator
- Ministry of Health, Saudi Arabiacollaborator
Study Sites (1)
Buraidah Diabetic Center
Buraidah, Al-Qassim, 52366, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazmus Saquib, PhD
Sulaiman Al-Rajhi Colleges
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2018
First Posted
February 27, 2018
Study Start
February 25, 2018
Primary Completion
August 25, 2018
Study Completion
December 25, 2018
Last Updated
February 27, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share