Cardiovascular Risk FactorNCT03796780
Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors
A study testing Extra-Virgin Olive Oil and Refined Olive Oil in people with Cardiovascular Risk Factor, run by Javad Nasrollahzadeh at 1 site in Iran.
Trial summary
Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Extra-Virgin Olive Oil and Refined Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2019to 1 Oct 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography
- willing to participation in the study
Who cannot join
- Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month
- َChronic kidney disease stage 5
- Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography
Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in patients with cardiovascular risk factors.
Read the detailed description
A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 40 eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Extra-Virgin Olive Oil, Refined Olive Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-Virgin Olive OilDietary supplement
Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks
Refined Olive OilDietary supplement
Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Extra-Virgin Olive Oil | Active comparator | Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks Receives: Dietary Supplement: Extra-Virgin Olive Oil |
| Refined Olive Oil | Placebo comparator | Daily consumption of 25 mL Refined Olive Oil for 6 weeks Receives: Dietary Supplement: Refined Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6)
change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6
Measured: 6 week
Secondary outcomes (4)
plasma lipid profile
change in plasma level of lipoproteins in mg/dL from baseline at 6 week
Measured: 6 week
plasma liver enzymes (SGOT & SGPT)
change in plasma level of liver enzymes (SGOT \& SGPT) in mg/dL from baseline at 6 week
Measured: 6 week
Interleukin-10 (IL-10)
Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6
Measured: 6 week
C reactive protein (CRP)
Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javad Nasrollahzadeh
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Sponsor-investigator, Javad Nasrollahzadeh, Shahid Beheshti University
- Investigators
- Javad Nasrollahzadeh, Ph.D, Study chair, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796780
- Sponsor's protocol ID
- 425
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2018
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khandouzi N, Zahedmehr A, Nasrollahzadeh J. Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial. Int J Food Sci Nutr. 2021 Jun;72(4):548-558. doi: 10.1080/09637486.2020.1841123. Epub 2020 Oct 29.
PubMed 33121297
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT03796780
- Acronym / sponsor ID
- 425
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Javad NasrollahzadehUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 8 Jan 2019 (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.
Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors. The purpose of this study is to compare the effects of extra-virgin olive oil and refined olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma lipid profile and inflammatory markers in patients with cardiovascular risk factors.
Detailed description
A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 40 eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra-Virgin Olive Oil | Active comparator | Dietary Supplement: Extra-Virgin Olive OilDaily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks |
| Refined Olive Oil | Placebo comparator | Dietary Supplement: Refined Olive OilDaily consumption of 25 mL Refined Olive Oil for 6 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) candidate for angiography
- willing to participation in the study
Key exclusion criteria (3 listed)
- Continuous consumption of any supplement with anti-inflammatory or antioxidant properties such as Omega-3, vitamin E, vitamin C and Selenium in last month
- َChronic kidney disease stage 5
- Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
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 OilDaily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks | Dietary supplement | Extra-Virgin Olive Oil |
| Refined Olive OilDaily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks | Dietary supplement | Refined Olive Oil |
Primary outcome
Interleukin-6 (IL-6)
Time frame: 6 week
change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6
4 secondary outcomes
plasma lipid profile
Time frame: 6 week
plasma liver enzymes (SGOT & SGPT)
Time frame: 6 week
Interleukin-10 (IL-10)
Time frame: 6 week
C reactive protein (CRP)
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Derived from this study: PubMed 33121297Khandouzi N, Zahedmehr A, Nasrollahzadeh J. Effect of polyphenol-rich extra-virgin olive oil on lipid profile and inflammatory biomarkers in patients undergoing coronary angiography: a randomised, controlled, clinical trial. Int J Food Sci Nutr. 2021 Jun;72(4):548-558. doi: 10.1080/09637486.2020.1841123. Epub 2020 Oct 29.
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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.
Javad Nasrollahzadeh, Ph.D study chair
Shahid Beheshti University of Medical Sciences
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 and Refined Olive Oil in people with Cardiovascular Risk Factor, run by Javad Nasrollahzadeh at 1 site in Iran.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Dec 2019. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796780, which also lists 1 linked publication.
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 10 Dec 2019.