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Clinical Trials/NCT04828447
NCT04828447
Completed
Not Applicable

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

University of Florida1 site in 1 country60 target enrollmentApril 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerotic Cardiovascular Disease
Sponsor
University of Florida
Enrollment
60
Locations
1
Primary Endpoint
Low Density Lipoprotein-Cholesterol
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 14, 2021
End Date
April 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients with borderline to high risk for ASCVD

Exclusion Criteria

  • Adult patients with known cardiovascular disease

Outcomes

Primary Outcomes

Low Density Lipoprotein-Cholesterol

Time Frame: 4 weeks

Change from Baseline

Study Sites (1)

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