Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
June 20, 2024 updated by: University of California, Davis
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Department of Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 41 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oleocanthal-Rich Extra Virgin Olive Oil
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
|
Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal
|
|
Placebo Comparator: Oleocanthal-Low Extra Virgin Olive Oil
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
|
Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, 2, 4 and 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-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.
|
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
|
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.
|
baseline, 2, 4 and 6 hours
|
|
Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins
Time Frame: baseline, 2, 4 and 6 hours
|
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.
|
baseline, 2, 4 and 6 hours
|
|
Influence of Oleocanthal-rich EVOO intake on Metabolomics
Time Frame: baseline, 2, 4 and 6 hours
|
Untargeted metabolomics will be performed to assess the relationship between platelet response and the presence of circulating plasma metabolites.
|
baseline, 2, 4 and 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2018
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
March 27, 2018
First Submitted That Met QC Criteria
May 4, 2018
First Posted (Actual)
May 18, 2018
Study Record Updates
Last Update Posted (Actual)
June 24, 2024
Last Update Submitted That Met QC Criteria
June 20, 2024
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1158686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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