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Dietary Supplement

Olive Oil for Heart Health

N/A
Waitlist Available
Led By Monica Aggarwal, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients with borderline to high risk for ASCVD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will compare clinical parameters of people with heart disease who eat a lot or a little olive oil.

Who is the study for?
This trial is for adults at moderate risk of heart-related diseases due to atherosclerosis, which is the buildup of fats and cholesterol in artery walls. Participants should not have been diagnosed with cardiovascular disease but be on the borderline or high risk for such conditions.Check my eligibility
What is being tested?
The study aims to see if eating a Whole Food Plant Based diet with different amounts of raw extra virgin olive oil (4 tablespoons vs less than 1 teaspoon) affects clinical parameters in patients at risk for heart disease caused by atherosclerosis.See study design
What are the potential side effects?
Since this trial involves dietary changes, side effects may include digestive changes depending on individual tolerance to olive oil. Other potential side effects are not specified but could relate to adjustments in diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at a borderline to high risk for heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Low Density Lipoprotein-Cholesterol

Side effects data

From 2014 Phase 3 trial • 379 Patients • NCT02009865
15%
All
12%
ALL
6%
Diarrhoea
4%
Nasopharyngitis
4%
Eructation
4%
Hypertension
2%
Constipation
2%
Dysgeusia
2%
Fatigue
1%
Nausea
1%
Gastroenteritis viral
1%
Hypoaesthesia
1%
Dizziness
1%
Cholelithiasis
1%
Pancreatitis
1%
Vomiting
1%
Bronchitis
1%
Erysipelas
1%
Aspartate aminotransferase increased
1%
Acne
1%
Toothache
1%
Dyspepsia
1%
Alanine aminotransferase increased
1%
Headache
1%
Food poisoning
1%
Nasal congestion
1%
Lipoma
1%
Flatulence
1%
Blood creatinine increased
1%
Blood glucose increased
1%
Gastric pH decreased
1%
Chills
1%
Coronary artery disease
1%
Influenza
1%
Respiratory tract infection viral
1%
Sialoadenitis
1%
Urinary tract infection
1%
Oropharyngeal pain
1%
Rhinitis allergi
1%
Upper respiratory tract congestion
1%
Gout
1%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epanova
Olive Oil

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Olive OilExperimental Treatment1 Intervention
There will be a total of 4 in-person clinic visits as well as 8 weekly remote cooking classes and individual sessions with a registered dietitian. Subject will first have a physical exam, have their blood (about 3 tablespoons) and urine collected, complete surveys, and talk about their eating style and meal planning. Subject will then follow a plant-based diet low in olive oil for 4 weeks before switching to the other type of diet for 4 weeks.
Group II: High Olive OilExperimental Treatment1 Intervention
There will be a total of 4 in-person clinic visits as well as 8 weekly remote cooking classes and individual sessions with a registered dietitian. Subject will first have a physical exam, have their blood (about 3 tablespoons) and urine collected, complete surveys, and talk about their eating style and meal planning. Subject will then follow a plant-based diet high in olive oil for 4 weeks before switching to the other type of diet for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olive Oil
2010
Completed Phase 4
~970

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,531 Total Patients Enrolled
Monica Aggarwal, MDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

Olive Oil (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04828447 — N/A
Cardiovascular Disease Research Study Groups: Low Olive Oil, High Olive Oil
Cardiovascular Disease Clinical Trial 2023: Olive Oil Highlights & Side Effects. Trial Name: NCT04828447 — N/A
Olive Oil (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04828447 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the population taking part in this research?

"Affirmative. The information hosted on clinicaltrials.gov affirms that this research endeavour, which was first publicized on April 14th 2021, is currently enrolling participants. 68 people require recruitment from one medical facility."

Answered by AI

Are there vacancies in this clinical trial for participants?

"The information on clinicaltrials.gov specifies that this study is currently seeking participants, and the trial was initially advertised on April 14th 2021 with its most recent edit taking place May 23rd 2022."

Answered by AI

Is this research study open to individuals more than 45 years of age?

"The minimum age of admission for this research is 18, and the upper limit is 100 years old."

Answered by AI

How might I join this medical experiment?

"Individuals suffering from heart problems and aged between 18 to 100 are eligible for this medical trial, where 68 participants will be taken in total."

Answered by AI
~0 spots leftby Apr 2024