Type 2 Diabetes MellitusNCT03447301
The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients
A study testing Extra virgin olive oil (30mL daily) in people with Type 2 Diabetes Mellitus, run by Sulaiman AlRajhi Colleges at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Extra virgin olive oil (30mL daily)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Feb 2018to 25 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Buraidah Diabetic Center
Buraidah, Al-Qassim, 52366
Saddik Zaghoul, MBBS, mohamed_saddik@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Extra virgin olive oil (30mL daily)
- Keywords
- Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra virgin olive oil (30mL daily)Dietary supplement
Intervention arm will take 30 mL of Extra virgin olive oil daily.
| Study group | Role | What they receive |
|---|---|---|
| Extra virgin olive oil | Experimental | Extra virgin olive oil (30mL) daily Receives: Dietary Supplement: Extra virgin olive oil (30mL daily) |
| Control | No intervention | No consumption of extra virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycated hemoglobin)
Measured: 3-month follow-up
Secondary outcomes (3)
Fasting Plasma Glucose
Measured: 3-month follow-up
Lipid Profile
High-density lipoprotein (HDL), Low-density lipoprotein (LDL), HDL/LDL ratio, triglycerides (TG), Cholesterol
Measured: 3-month follow-up
Weight
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start25 Feb 2018 (estimated)
- Primary completion25 Aug 2018 (estimated)
- Study completion25 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sulaiman AlRajhi Colleges
- Sponsor type
- University, hospital or other
- Collaborators
- Qassim University, Ministry of Health, Saudi Arabia
- Responsible party
- Sponsor
- Investigators
- Nazmus Saquib, PhD, Principal investigator, Sulaiman Al-Rajhi Colleges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447301
- Sponsor's protocol ID
- SulaimanAC
- Status last verified
- Feb 2018
- First submitted
- 18 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03447301
- Acronym / sponsor ID
- SulaimanAC
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Saudi Arabia, Extra Virgin Olive Oil, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sulaiman AlRajhi CollegesUniversity, hospital or other
- Collaborators
- Qassim University, Ministry of Health, Saudi Arabia
- Study start
- 25 Feb 2018 (estimated)
- Primary completion
- 25 Aug 2018 (estimated)
- Study completion
- 25 Dec 2018 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra virgin olive oil | Experimental | Dietary Supplement: Extra virgin olive oil (30mL daily)Extra virgin olive oil (30mL) daily |
| Control | No intervention | –No consumption of extra virgin olive oil |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra virgin olive oil (30mL daily)Intervention arm will take 30 mL of Extra virgin olive oil daily. | Dietary supplement | Extra virgin olive oil |
Primary outcome
HbA1c (glycated hemoglobin)
Time frame: 3-month follow-up
3 secondary outcomes
Fasting Plasma Glucose
Time frame: 3-month follow-up
Lipid Profile
Time frame: 3-month follow-up
Weight
Time frame: 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazmus Saquib, PhD principal investigator
Sulaiman Al-Rajhi Colleges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra virgin olive oil (30mL daily) in people with Type 2 Diabetes Mellitus, run by Sulaiman AlRajhi Colleges at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazmus Saquib, PhD (966 0533445899, a.saquib@sr.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (glycated hemoglobin) (time frame: 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.