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

NCT ID: NCT03447301

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-25

Study Completion Date

2018-12-25

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extra virgin olive oil

Extra virgin olive oil (30mL) daily

Group Type EXPERIMENTAL

Extra virgin olive oil (30mL daily)

Intervention Type DIETARY_SUPPLEMENT

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

Control

No consumption of extra virgin olive oil

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extra virgin olive oil (30mL daily)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qassim University

OTHER

Sponsor Role collaborator

Ministry of Health, Saudi Arabia

OTHER_GOV

Sponsor Role collaborator

Sulaiman AlRajhi Colleges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nazmus Saquib, PhD

Role: PRINCIPAL_INVESTIGATOR

Sulaiman Al-Rajhi Colleges

Locations

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Buraidah Diabetic Center

Buraidah, Al-Qassim, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Nazmus Saquib, PhD

Role: CONTACT

966 0533445899

Juliann Saquib, PhD

Role: CONTACT

966 507136832

Facility Contacts

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Saddik Zaghoul, MBBS

Role: primary

Other Identifiers

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SulaimanAC

Identifier Type: -

Identifier Source: org_study_id

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