Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03528603
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Aggregation; Nutritional and Metabolic Disease; Cardiovascular Diseases	Other: Oleocanthal-Rich Extra Virgin Olive Oil; Other: Oleocanthal-low Extra Virgin Olive Oil	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: controlled, randomized, double-blind, with 2 interventionscontrolled, randomized, double-blind, with 2 interventions
• Masking: Double (Participant, Investigator)
• Masking Description: Extra Virgin Olive Oils will be stored and provided to the study investigators in coded single serving bottles
• Primary Purpose: Basic Science
• Official Title: Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition
• Actual Study Start Date: Apr 2, 2018
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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	Other: Oleocanthal-Rich Extra Virgin Olive Oil; Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal; Other: Oleocanthal-low Extra Virgin Olive Oil; 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	Other: Oleocanthal-Rich Extra Virgin Olive Oil; Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal; Other: Oleocanthal-low Extra Virgin Olive Oil; Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal

Outcome Measures

Primary Outcome Measures

1. Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry [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.

Secondary Outcome Measures

1. Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry [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.

2. Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry [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.

3. Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins [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.

4. Influence of Oleocanthal-rich EVOO intake on Metabolomics [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition	Davis	California	United States	95616

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Learn more or sign up for the study here!

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03528603
• Other Study ID Numbers: 1158686
• First Posted: May 18, 2018
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, Davis: platelet, aggregation, phenolic, olive oil, oleocanthal
• Additional relevant MeSH terms: Cardiovascular Diseases; Metabolic Diseases

Study Results

No Results Posted as of Jun 6, 2022