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NCT04828447 Clinical Trial

Recipe for Heart Health

Atherosclerotic Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04828447
Other study ID # Recipe for Heart Health
Secondary ID IRB202002194
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 14, 2021
Est. completion date April 1, 2024

Study information
Verified date May 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: -Adult patients with borderline to high risk for ASCVD Exclusion Criteria: -Adult patients with known cardiovascular disease

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Olive Oil
Subjects will be randomized to either high or low dose of olive oil and follow a whole food plant based diet.

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Low Density Lipoprotein-Cholesterol Change from Baseline 4 weeks
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