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Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

Primary Purpose

Platelet Aggregation, Nutritional and Metabolic Disease, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oleocanthal-Rich Extra Virgin Olive Oil
Oleocanthal-low Extra Virgin Olive Oil
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Platelet Aggregation focused on measuring platelet, aggregation, phenolic, olive oil, oleocanthal

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oleocanthal-Rich Extra Virgin Olive Oil

Oleocanthal-Low Extra Virgin Olive Oil

Arm Description

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 is low in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Rich Extra Virgin Olive Oil

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 27, 2018
Last Updated
May 9, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03528603
Brief Title
Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
Official Title
Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Aggregation, Nutritional and Metabolic Disease, Cardiovascular Diseases
Keywords
platelet, aggregation, phenolic, olive oil, oleocanthal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
controlled, randomized, double-blind, with 2 interventions
Masking
ParticipantInvestigator
Masking Description
Extra Virgin Olive Oils will be stored and provided to the study investigators in coded single serving bottles
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oleocanthal-Rich Extra Virgin Olive Oil
Arm Type
Experimental
Arm Description
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
Arm Title
Oleocanthal-Low Extra Virgin Olive Oil
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Oleocanthal-Rich Extra Virgin Olive Oil
Intervention Description
Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
Intervention Type
Other
Intervention Name(s)
Oleocanthal-low Extra Virgin Olive Oil
Intervention Description
Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal
Primary Outcome Measure Information:
Title
Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry
Description
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.
Time Frame
baseline, 2, 4 and 6 hours
Secondary Outcome Measure Information:
Title
Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry
Description
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.
Time Frame
baseline, 2, 4 and 6 hours
Title
Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry
Description
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.
Time Frame
baseline, 2, 4 and 6 hours
Title
Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins
Description
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.
Time Frame
baseline, 2, 4 and 6 hours
Title
Influence of Oleocanthal-rich EVOO intake on Metabolomics
Description
Untargeted metabolomics will be performed to assess the relationship between platelet response and the presence of circulating plasma metabolites.
Time Frame
baseline, 2, 4 and 6 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta R Holt, PhD
Phone
530-752-4950
Email
rrholt@ucdavis.edu
Facility Information:
Facility Name
Department of Nutrition
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta R Holt, PhD
Phone
530-752-4950
Email
rrholt@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://studypages.com/s/study-of-the-effects-of-extra-virgin-olive-oil-polyphenols-on-cardiovascular-health-162282/
Description
Learn more or sign up for the study here!

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Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

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