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OpenTrials
Completed

NCT Number: NCT04828447

Recipe for Heart Health

The overall objectives of this project are to compare clinical parameters in moderate risk Atherosclerotic Cardiovascular Disease (ASCVD) patients following a Whole Food Plant Based (WFPB) diet containing a high (4 TB) compared to a low (<1 tsp) amount of raw extra virgin olive oil.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

Up to sixty-eight primary prevention outpatient adults with intermediate to high ASCVD risk factors will be randomized in a crossover fashion to follow a WFPB diet without animal products that is either high (4 tablespoons) or low (< ~1 teaspoon) in raw extra virgin olive oil. After confirming eligibility and patients provide consent, the research team will randomize the participant at the baseline visit. The baseline visit and run-in visit 1 will follow as described below. With the intent of recruiting cohorts of ten, a group of participants will subsequently begin the first Whole Food Plant Based culinary diet intervention for four weeks, followed by a one-week (+ 3 days) washout period before switching to the opposite oil diet for an additional four weeks. During each of the 4-week interventions, participants will attend weekly cooking sessions that align with the dietary intervention with a registered dietitian. Patients will be asked to maintain levels of physical activity through the duration of the study. Data will be collected at the patient's cardiology visits before and after each diet intervention for a total of four in-person visits excluding the screening visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Adult patients with borderline to high risk for ASCVD

Exclusion criteria

-Adult patients with known cardiovascular disease

Treatment and study plan

Olive Oil

Dietary Supplement

Subjects will be randomized to either high or low dose of olive oil and follow a whole food plant based diet.

Primary outcomes

  1. Low Density Lipoprotein-Cholesterol

    Time frame: 4 weeks

    Change from Baseline

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Recipe for Heart Health: A Plant-Based Culinary Diet Intervention to Test Independent Benefits of Olive Oil

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Apr 2, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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