A Multicenter Pilot Study to Evaluate the Effect of EVOO on Lipid Parameters
Completed · Not applicable
Conditions studied: Cardiovascular Diseases
In brief
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 diagnosed with cardiovascular disease (CVD) and to determine if the polyphenol concentration is proportional to those effects. Subjects will complete consecutive 28-day periods (with a 14-day washout between) in which they will either consume the low polyphenol concentration EVOO daily or the high polyphenol concentration EVOO. In a double-blinded manner, each subject will be his or her own control with a 14-day washout between study periods. HDL levels and other parameters will be measured after each period of the protocol. The investigators anticipate HDL levels will improve with both olive oils. The investigators expect the high polyphenol concentration EVOO will show a greater effect than the EVOO with a low polyphenol concentration. EVOO with high polyphenol concentration may be a simple method to reduce the risk of secondary CVD events.
Key facts
- Study ID
- NCT04760093
- Run by
- Ralph Hamill
- People needed
- 23
- Starts
- 2021-07-26
- Expected to finish
- 2022-12-22
- Last updated by the study team
- 2023-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mid Coast Cardiology — Brunswick, Maine, United States
- Pen Bay Medical Center — Rockport, Maine, United States
- Maine Medical Partners Cardiology — Scarborough, Maine, United States
Full record on ClinicalTrials.gov
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