Platelet AggregationNCT03528603
Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
A study testing Oleocanthal-Rich Extra Virgin Olive Oil and Oleocanthal-low Extra Virgin Olive Oil in people with Platelet Aggregation and Nutritional and Metabolic Disease, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators have previously observed a reduced level of platelet aggregation 2 hours after healthy male individuals were asked to drink extra virgin olive oil (EVOO) that provided a higher level of one specific phenolic known as oleocanthal. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation, Nutritional and Metabolic Disease, Cardiovascular Diseases
- What is being tested?
- Oleocanthal-Rich Extra Virgin Olive Oil and Oleocanthal-low Extra Virgin Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 31 May 2024
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Trials 1 and 2: Male; Trial 3: Male and Female
- 20-45 years old
- For females, a regular 25-30-day menstrual cycle
- Subject is willing and able to comply with the study protocols
- Subject is willing to drink 40 mL (approximately 2 tablespoons) of olive oil
- BMI 18.5 - 30 kg/m2
- Weight ≥ 110 pounds
Who cannot join
- Adults who are not able to consent
- BMI ≥ 31 kg/m2
- Under current medical supervision
- 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of < 65%.
- Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the UCD Med Center
- Current diagnosis of anemia; or a screening hemoglobin and hematocrit that is less than the normal reference range.
Show all 21Show fewer
- Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
- Females using hormonal contraception
- Ibuprofen intolerance or allergy
- Those with a bleeding disorder
- Non-English speaking
- Allergy to olives or olive oil
- Vegetarian, Vegan, food faddists, individuals using non-traditional diets, or on a weight loss diet.
- 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 for six weeks prior to study enrollment.
- Not willing to refrain from olive oil consumption for 4 weeks prior to study enrollment, and throughout study enrollment
- Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
- Current enrollee in a clinical research study.
- Individuals with blood clotting or platelet defect disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition
The investigators have previously observed a reduced level of platelet aggregation 2 hours after healthy male individuals were asked to drink extra virgin olive oil (EVOO) that provided a higher level of one specific phenolic known as oleocanthal. This study will help the investigators further determine the effects of oleocanthal-rich EVOO intake on platelet function at 2, 4 and 6 hours after intake with food compared to platelet function in the morning after an overnight fast.
Read the detailed description
Fifty adult male volunteers will be asked to participate in one of two study trials that will be randomized double-blind controlled crossover trials with 2 study visits. The participants will arrive to the facility after an overnight fast, and will be asked to consume their assigned EVOO either without (trial 1) or with (trial 2) a standardized low-phenolic food (such as rice, pasta or mashed potatoes) with 40 mL of one of 2 EVOOs that are matched for their total phenolic content, but with one oil containing oleocanthal, and one with very low levels of oleocanthal. At zero, two, 4 and 6 hours after EVOO intake a blood sample will be collected for the assessment of collagen- ADP-, and AA-induced platelet aggregation, as well as an untargeted metabolomics profile.
As an assessment of phenotypic stability, a subset of individuals (n=5 per trial) that have exhibit either low or high platelet responses, will be asked to repeat the above study.
- Being tested
- Oleocanthal-Rich Extra Virgin Olive Oil, Oleocanthal-low Extra Virgin Olive Oil
- Keywords
- platelet, aggregation, phenolic, olive oil, oleocanthal
- Medical subject headings
- Metabolic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleocanthal-Rich Extra Virgin Olive OilOther
Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
Oleocanthal-low Extra Virgin Olive OilOther
Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal
| Study group | Role | What they receive |
|---|---|---|
| Oleocanthal-Rich Extra Virgin Olive Oil | Experimental | Extra Virgin Olive Oil that is high in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Low Extra Virgin Olive Oil Receives: Other: Oleocanthal-Rich Extra Virgin Olive Oil; Other: Oleocanthal-low Extra Virgin Olive Oil |
| Oleocanthal-Low Extra Virgin Olive Oil | Placebo comparator | Extra Virgin Olive Oil that is low in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Rich Extra Virgin Olive Oil Receives: Other: Oleocanthal-Rich Extra Virgin Olive Oil; Other: Oleocanthal-low Extra Virgin Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry
Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.
Measured: baseline, 2, 4 and 6 hours
Secondary outcomes (4)
Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry
Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.
Measured: baseline, 2, 4 and 6 hours
Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry
Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.
Measured: baseline, 2, 4 and 6 hours
Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins
Oxylipin profile will be conducted from the activated platelet supernatant ultra high-performance liquid chromatography-mass spectrometry (HPLC) is used to measure levels of oxylipin. HPLC area under the peak will be measured.
Measured: baseline, 2, 4 and 6 hours
Influence of Oleocanthal-rich EVOO intake on Metabolomics
Untargeted metabolomics will be performed to assess the relationship between platelet response and the presence of circulating plasma metabolites.
Measured: baseline, 2, 4 and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start2 Apr 2018
- Primary completion1 Mar 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet AggregationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- controlled, randomized, double-blind, with 2 interventions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528603
- Sponsor's protocol ID
- 1158686
- Status last verified
- May 2023
- First submitted
- 27 Mar 2018
- Last updated
- 24 Jun 2024
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition
- ClinicalTrials.gov ID
- NCT03528603
- Acronym / sponsor ID
- 1158686
- Keywords
- platelet, aggregation, phenolic, olive oil, oleocanthal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 May 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.
The investigators have previously observed a reduced level of platelet aggregation 2 hours after healthy male individuals were asked to drink extra virgin olive oil (EVOO) that provided a higher level of one specific phenolic known as oleocanthal. This study will help the investigators further determine the effects of oleocanthal-rich EVOO intake on platelet function at 2, 4 and 6 hours after intake with food compared to platelet function in the morning after an overnight fast.
Detailed description
Fifty adult male volunteers will be asked to participate in one of two study trials that will be randomized double-blind controlled crossover trials with 2 study visits. The participants will arrive to the facility after an overnight fast, and will be asked to consume their assigned EVOO either without (trial 1) or with (trial 2) a standardized low-phenolic food (such as rice, pasta or mashed potatoes) with 40 mL of one of 2 EVOOs that are matched for their total phenolic content, but with one oil containing oleocanthal, and one with very low levels of oleocanthal. At zero, two, 4 and 6 hours after EVOO intake a blood sample will be collected for the assessment of collagen- ADP-, and AA-induced platelet aggregation, as well as an untargeted metabolomics profile.
As an assessment of phenotypic stability, a subset of individuals (n=5 per trial) that have exhibit either low or high platelet responses, will be asked to repeat the above study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- controlled, randomized, double-blind, with 2 interventions
| Arm | Type | Receives |
|---|---|---|
| Oleocanthal-Rich Extra Virgin Olive Oil | Experimental | Other: Oleocanthal-Rich Extra Virgin Olive Oil, Other: Oleocanthal-low Extra Virgin Olive OilExtra Virgin Olive Oil that is high in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Low Extra Virgin Olive Oil |
| Oleocanthal-Low Extra Virgin Olive Oil | Placebo comparator | Other: Oleocanthal-Rich Extra Virgin Olive Oil, Other: Oleocanthal-low Extra Virgin Olive OilExtra Virgin Olive Oil that is low in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Rich Extra Virgin Olive Oil |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Trials 1 and 2: Male; Trial 3: Male and Female
- 20-45 years old
- For females, a regular 25-30-day menstrual cycle
- Subject is willing and able to comply with the study protocols
- Subject is willing to drink 40 mL (approximately 2 tablespoons) of olive oil
Key exclusion criteria (21 listed)
- Adults who are not able to consent
- BMI ≥ 31 kg/m2
- Under current medical supervision
- 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of < 65%.
- Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the UCD Med Center
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 |
|---|---|---|
| Oleocanthal-Rich Extra Virgin Olive OilExtra Virgin Olive Oil that contains a high level of the phenolic oleocanthal | Other | Oleocanthal-Low Extra Virgin Olive Oil, Oleocanthal-Rich Extra Virgin Olive Oil |
| Oleocanthal-low Extra Virgin Olive OilExtra Virgin Olive Oil that contains a low level of the phenolic oleocanthal | Other | Oleocanthal-Low Extra Virgin Olive Oil, Oleocanthal-Rich Extra Virgin Olive Oil |
Primary outcome
Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry
Time frame: baseline, 2, 4 and 6 hours
Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.
4 secondary outcomes
Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry
Time frame: baseline, 2, 4 and 6 hours
Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry
Time frame: baseline, 2, 4 and 6 hours
Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins
Time frame: baseline, 2, 4 and 6 hours
Influence of Oleocanthal-rich EVOO intake on Metabolomics
Time frame: baseline, 2, 4 and 6 hours
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 24 Jun 2024.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Cookies for Platelets
Blood Donation
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 Oleocanthal-Rich Extra Virgin Olive Oil and Oleocanthal-low Extra Virgin Olive Oil in people with Platelet Aggregation and Nutritional and Metabolic Disease, run by University of California, Davis at 1 site in United States.
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 7 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 24 Jun 2024. 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 States. 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?
Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry (time frame: baseline, 2, 4 and 6 hours). 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 24 Jun 2024.