Recipe for Heart Health

NCT ID: NCT04828447

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2024-04-01

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.

Conditions

Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High Olive Oil

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.

Group Type: EXPERIMENTAL

Olive Oil

Intervention Type: DIETARY_SUPPLEMENT

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

Low Olive Oil

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 Type: EXPERIMENTAL

Olive Oil

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Olive Oil

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

-Adult patients with borderline to high risk for ASCVD

Exclusion Criteria

-Adult patients with known cardiovascular disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Aggarwal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

Krenek AM, Mathews A, Guo J, Courville AB, Pepine CJ, Chung ST, Aggarwal M. Recipe for Heart Health: A Randomized Crossover Trial on Cardiometabolic Effects of Extra Virgin Olive Oil Within a Whole-Food Plant-Based Vegan Diet. J Am Heart Assoc. 2024 Aug 6;13(15):e035034. doi: 10.1161/JAHA.124.035034. Epub 2024 Jul 24.

Reference Type: DERIVED

PMID: 39045758 (View on PubMed)

Other Identifiers

IRB202002194

Identifier Type: OTHER

Identifier Source: secondary_id

Recipe for Heart Health

Identifier Type: -

Identifier Source: org_study_id