MedTrace Logo

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

NCT04760093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Low polyphenol concentration extra virgin olive oil (EVOO)

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

DIETARY_SUPPLEMENT

High polyphenol concentration extra virgin olive oil (EVOO)

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

Sponsors & Collaborators

  • Ralph Hamill

    lead OTHER

Principal Investigators

  • Ralph Hamill, MD · Maine Medical Partners

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2022-12-22
Completion
2022-12-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760093 on ClinicalTrials.gov