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Recipe for Heart Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04828447
Enrollment
60
Registered
2021-04-02
Start date
2021-04-14
Completion date
2024-04-01
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease

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.

Interventions

DIETARY_SUPPLEMENTOlive Oil

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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Pilot prospective randomized crossover clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

-Adult patients with borderline to high risk for ASCVD

Exclusion criteria

-Adult patients with known cardiovascular disease

Design outcomes

Primary

MeasureTime frameDescription
Low Density Lipoprotein-Cholesterol4 weeksChange from Baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026