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Cardiovascular DiseasesNCT02902913

Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

A study testing D2i2, D2i0.5 and D2i0 in people with Cardiovascular Diseases, run by University of California, Davis.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Data from limited dietary intervention trials suggest that the cardiovascular health benefit of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs contain an array of bioactive compounds, little information exists regarding the physiological effects of specific chemical species. Read more about this study

Who is it for?
Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
D2i2, D2i0.5 and D2i0
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
No sites listed yet
Study dates
Jan 2015to Sep 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willing and able to comply with study protocols
  • Willing to drink 2 tablespoons of olive oil
  • BMI 18.5 to 30 kg/m2
  • Weight ≥ 110 pounds

Who cannot join

  • Adults who are not able to consent
  • BMI ≥ 31 kg/m2
  • Under current medical supervision
  • Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
  • Ibuprofen intolerance or allergy
  • Cannot speak English
Show all 21Show fewer
  • Allergy to olives or olive oil
  • Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet of the general population.
  • A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
  • Currently taking prescription drugs or supplements
  • Indications of substance or alcohol abuse within the last 3 years
  • Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements.
  • Not willing to refrain from olive oil consumption.
  • Blood Pressure ≥ 140/90 mmHg
  • Self-reported malabsorption
  • Metabolic panel results or complete blood counts that are outside of the normal reference range.
  • Screening LDL ≥ 190 mg/dl for those who have 0 - 1 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
  • Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
  • Screening LDL ≥ than 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol ((i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL), and a Framingham 10 - year Risk Score 10 - 20 % (using NCEP calculator).
  • Current enrollee in a clinical research study.
  • Individuals with blood clotting or platelet defect disorders

About this study

Official title: Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity in Healthy Humans

Data from limited dietary intervention trials suggest that the cardiovascular health benefit of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs contain an array of bioactive compounds, little information exists regarding the physiological effects of specific chemical species. Among the EVOO-derived phenolics with demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40 mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were randomly assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were characterized and chosen for equivalency in their total phenolic content and fatty acid profiles, but differing in their oleocanthal to oleacein ratio.

Read the detailed description

Ten healthy adult males (20-50 years of age) will be enrolled into a randomized triple-blind, controlled crossover study that will test the acute effects of oleocanthal-rich extra virgin olive oil intake on platelet aggregation. Each participant will be asked to participate in four study days, separated by at least 1-week, in which they will be randomized to consume on each study day 40 mL (~3 tablespoons) of either oleocanthal-rich extra virgin olive oil (OO), or an extra virgin OO that is matched in total phenolics but oleocanthal-poor, or a refined OO that is low in all phenolics In addition to the oils, on a fourth study day visit, after completion of the study visits involving oil intake the subjects will be asked to take 400mg of ibuprofen.

Collection procedures will be performed at the same time of the day to avoid circadian effects. A blood sample (50 mL ~ 3.5 tbsp) will be collected for the measurement of platelet aggregometry and COX metabolites. Following this initial blood draw, the subjects will consume their assigned test product for the day. Two-hours following the intake of the assigned olive oil, a second blood sample will be drawn (50 mL ~ 3.5 tbsp). After the second blood draw, the study day will be complete.

Being tested
D2i2, D2i0.5, D2i0, Ibuprofen
Keywords
platelet reactivity, phenolic, extra virgin olive oil, cyclooxygenase, oleocanthal, oxylipin
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D2i2Other

    Also called Oleocanthal-rich

    Oleocanthal provided in a 2:1 ratio compared to oleacein

  • D2i0.5Other

    Also called Oleocanthal-low

    Oleocanthal provided in a 1:2 ratio compared to oleacein

  • D2i0Other

    Also called Control EVOO

    No oleocanthal and no oleacein

  • IbuprofenDrug

    400 mg of Ibuprofen

Study groups in NCT02902913
Study groupRoleWhat they receive
Oleocanthal-rich, D2i2ExperimentalOleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio)
Receives: Other: D2i2
Oleacein-rich, D2i0.5ExperimentalOleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio)
Receives: Other: D2i0.5
Oleocanthal and Oleacein-low, D2i0Placebo comparatorOleocanthal and Oleacein-low, D2i0 (Extra virgin olive oil containing low amounts of oleocanthal to oleacein, but with a similar total phenolic content as the other two oils)
Receives: Other: D2i0
IbuprofenActive comparatorIbuprofen, 400 mg
Receives: Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optical Platelet Aggregometry

    Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry

    Measured: Change from baseline 2 hours post intake

Secondary outcomes (1)

  1. Activated Platelet Oxylipin Production

    Oxylipins derived from cyclooxygenase, lipoxygenase, and cytochrome P450 dependent metabolism of AA were quantified using liquid chromatography with tandem mass spectrometry (LC-MS/MS) in 100 µL of PRP plasma activated with collagen or ADP as well as 100 µL of unactivated PRP plasma collected before and two hours after treatment with EVOO or ibuprofen.

    Data were mean centered and reported as a % change from baseline.

    Measured: Change from baseline 2 hours post intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02902913
Sponsor's protocol ID
617247
Status last verified
Mar 2021
First submitted
7 Sep 2016
Last updated
27 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agrawal K, Melliou E, Li X, Pedersen TL, Wang SC, Magiatis P, Newman JW, Holt RR. Oleocanthal-rich extra virgin olive oil demonstrates acute anti-platelet effects in healthy men in a randomized trial. J Funct Foods. 2017 Sep;36:84-93. doi: 10.1016/j.jff.2017.06.046. Epub 2017 Jul 3.

    PubMed 29904393

Questions about this trial

What is this clinical trial studying?

A study testing D2i2, D2i0.5 and D2i0 in people with Cardiovascular Diseases, run by University of California, Davis.

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 21 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Optical Platelet Aggregometry (time frame: Change from baseline 2 hours post intake). 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 NCT02902913, 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 27 Apr 2021.

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