Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528603
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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 Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: controlled, 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 : April 2, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528603


Contacts
Layout table for location contacts
Contact: Roberta R Holt, PhD 530-752-4950 rrholt@ucdavis.edu

Locations
Layout table for location information
United States, California
Department of Nutrition Recruiting
Davis, California, United States, 95616
Contact: Roberta R Holt, PhD    530-752-4950    rrholt@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis

Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03528603     History of Changes
Other Study ID Numbers: 1158686
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Metabolic Diseases
Cardiovascular Diseases