Atherosclerotic Cardiovascular Disease
Conditions
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
Subjects will be randomized to either high or low dose of olive oil and follow a whole food plant based diet.
Sponsors
Study design
Intervention model description
Pilot prospective randomized crossover clinical trial
Eligibility
Inclusion criteria
-Adult patients with borderline to high risk for ASCVD
Exclusion criteria
-Adult patients with known cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Density Lipoprotein-Cholesterol | 4 weeks | Change from Baseline |
Countries
United States