Status:
COMPLETED
A Multicenter Pilot Study to Evaluate the Effect of EVOO on Lipid Parameters
Lead Sponsor:
Ralph Hamill
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this multi-center, double-blinded pilot study is to determine if extra virgin olive oil (EVOO) has a positive effect on HDL cholesterol levels and anti-inflammatory markers for subjects...
Detailed Description
Study Design: A multi-center, double-blinded pilot study to determine if extra virgin olive oil (EVOO) has a positive effect on HDL cholesterol levels and anti-inflammatory markers for subjects diagn...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Both males and females will be included
- Known cardiovascular disease as documented by ICD code
- HDL \< 40 documented within the past 12 months
- Able to fast for 12 hours prior to blood draws
Exclusion
- Unwilling or unable to provide informed consent for any reason
- Inability to adhere to protocol for any reason
- Currently using EVOO on a daily basis
- Change in use of lipid lowering medications or supplements in the past 90 days or plans to change during study participation
- HDL \> 40 on baseline blood draw
- Significant change in diet or exercise in the past 30 days or plan to do so during the study time period
- Allergic to olive oil
- Unable to fast for 12 hours prior to blood draws
- Pregnancy
- Enrolled in another interventional research study
- Non-English speaking
Key Trial Info
Start Date :
July 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04760093
Start Date
July 26 2021
End Date
December 22 2022
Last Update
March 24 2023
Active Locations (3)
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1
Mid Coast Cardiology
Brunswick, Maine, United States, 04011
2
Pen Bay Medical Center
Rockport, Maine, United States, 04856
3
Maine Medical Partners Cardiology
Scarborough, Maine, United States, 04074