Recipe for Heart Health

NCT04828447 | Completed

• 2 other identifiers: Recipe for Heart HealthIRB202002194
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Low Density Lipoprotein-Cholesterol

  Change from Baseline

  4 weeks

Study Arms (2)

High Olive Oil

EXPERIMENTAL

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.

Dietary Supplement: Olive Oil

Low Olive Oil

EXPERIMENTAL

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.

Dietary Supplement: Olive Oil

Interventions

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.

High Olive Oil; Low Olive Oil

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with borderline to high risk for ASCVD

You may not qualify if:

• Adult patients with known cardiovascular disease

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 39045758 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Monica Aggarwal, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot prospective randomized crossover clinical trial

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 2, 2021
• Study Start: April 14, 2021
• Primary Completion: June 22, 2022
• Study Completion: April 1, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)