Cardiovascular Risk FactorNCT04187638
Effect of Olive Oil Consumption on Cardiovascular Biomarkers
A study testing Olive oil and Butter in people with Cardiovascular Risk Factor, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The main aim of this study is to examine the effect of olive oil consumption on several cardiovascular risk markers between Caucasians and Asian ethnicity. The primary assessments: endothelial function's biomarkers: cell and vascular adhesion molecules (ICAMs and VCAMs) and nitric oxide (NO). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Olive oil and Butter
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2019to 1 Aug 2020
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Orient Asians (including Chinese, Japanese, Korean, and Malaysia Chinese) and Caucasians
- Age 18-70 years
- Self-reported in good general health
Who cannot join
- Female
- Age older than 70 years or younger than 18 years
- Diagnosed and/or are taking medications for hypertension (>140/90mmHg)
- Diabetes
- High blood cholesterol
- Heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome)
Show all 9Show fewer
- Allergy to olive oil or olive oil products
- Lactose intolerance
- Taking omega-3 supplements in fish oil and vitamins supplements in the last six months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Effect of Olive Oil Consumption on Cardiovascular Biomarkers in Asians and Caucasians: A Randomized, Crossover, Controlled Interventional Trial
The main aim of this study is to examine the effect of olive oil consumption on several cardiovascular risk markers between Caucasians and Asian ethnicity. The primary assessments: endothelial function's biomarkers: cell and vascular adhesion molecules (ICAMs and VCAMs) and nitric oxide (NO). The secondary assessments: Lipid profile.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Olive oil, Butter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oilDietary supplement
Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.
ButterDietary supplement
Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.
| Study group | Role | What they receive |
|---|---|---|
| Olive oil | Experimental | Participants will receive 30ml/day of olive oil for two weeks Receives: Dietary Supplement: Olive oil; Dietary Supplement: Butter |
| Butter | Placebo comparator | Participants will receive 30g/day of butter also for two weeks. Receives: Dietary Supplement: Olive oil; Dietary Supplement: Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in ambulatory blood pressure
Measured: Baseline and 2 weeks
Secondary outcomes (4)
Changes in plasma total cholesterol
Plasma total cholesterol vascular cell adhesion molecule 1
Measured: Baseline and 2 weeks
Changes in Intercellular Adhesion Molecule 1
Plasma levels of Intercellular Adhesion Molecule 1 measured
Measured: Baseline and 2 weeks
Changes in vascular cell adhesion molecule 1
Plasma levels of vascular cell adhesion molecule 1 measured
Measured: Baseline and 2 weeks
Changes in C-reactive protein
Plasma levels of CRP measured
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start31 Jan 2019
- Primary completion31 Dec 2019
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, double-blind, placebo-controlled crossover trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Lara Gallegos, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187638
- Sponsor's protocol ID
- HLS-JLG-OOstudy
- Status last verified
- Mar 2020
- First submitted
- 28 Nov 2019
- Last updated
- 17 Mar 2020
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olive Oil Consumption on Cardiovascular Biomarkers in Asians and Caucasians: A Randomized, Crossover, Controlled Interventional Trial
- ClinicalTrials.gov ID
- NCT04187638
- Acronym / sponsor ID
- HLS-JLG-OOstudy
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 5 Dec 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.
The main aim of this study is to examine the effect of olive oil consumption on several cardiovascular risk markers between Caucasians and Asian ethnicity. The primary assessments: endothelial function's biomarkers: cell and vascular adhesion molecules (ICAMs and VCAMs) and nitric oxide (NO). The secondary assessments: Lipid profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Olive oil | Experimental | Dietary Supplement: Olive oil, Dietary Supplement: ButterParticipants will receive 30ml/day of olive oil for two weeks |
| Butter | Placebo comparator | Dietary Supplement: Olive oil, Dietary Supplement: ButterParticipants will receive 30g/day of butter also for two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Orient Asians (including Chinese, Japanese, Korean, and Malaysia Chinese) and Caucasians
- Age 18-70 years
- Self-reported in good general health
Key exclusion criteria (9 listed)
- Female
- Age older than 70 years or younger than 18 years
- Diagnosed and/or are taking medications for hypertension (>140/90mmHg)
- Diabetes
- High blood cholesterol
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 |
|---|---|---|
| Olive oilParticipants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments. | Dietary supplement | Butter, Olive oil |
| ButterParticipants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments. | Dietary supplement | Butter, Olive oil |
Primary outcome
changes in ambulatory blood pressure
Time frame: Baseline and 2 weeks
4 secondary outcomes
Changes in plasma total cholesterol
Time frame: Baseline and 2 weeks
Changes in Intercellular Adhesion Molecule 1
Time frame: Baseline and 2 weeks
Changes in vascular cell adhesion molecule 1
Time frame: Baseline and 2 weeks
Changes in C-reactive protein
Time frame: Baseline and 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil and Butter in people with Cardiovascular Risk Factor, run by Northumbria University at 1 site in United Kingdom.
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 9 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 17 Mar 2020. 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 United Kingdom. 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?
Results are not available in the source record.
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?
changes in ambulatory blood pressure (time frame: Baseline and 2 weeks). 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 17 Mar 2020.