NCT04828447

Recipe for Heart Health

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-06-22
• Completion: 2024-04-01
• First posted: 2021-04-02
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States