CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Low polyphenol concentration extra virgin olive oil (EVOO) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04760093
NCT04760093N/ACompleted

A Multicenter Pilot Study to Evaluate the Effect of EVOO on Lipid Parameters

Ralph Hamill·interventional·Posted Feb 18, 2021·Updated Mar 24, 2023

In Brief

A clinical study evaluating Low polyphenol concentration extra virgin olive oil (EVOO) and High polyphenol concentration extra virgin olive oil (EVOO) for Cardiovascular Diseases. Completed, enrolled 23 participants across 3 sites.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 18, 2021
Enrollment StartJul 26, 2021
Primary CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.4 years ago

Interventions

Low polyphenol concentration extra virgin olive oil (EVOO)dietary

Subjects will complete a consecutive 28-day period of consuming low polyphenol concentration EVOO daily.

High polyphenol concentration extra virgin olive oil (EVOO)dietary

Subjects will complete a consecutive 28-day period of consuming high polyphenol concentration EVOO daily.