A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.

Completed · Not applicable

Conditions studied: Cardiovascular Diseases, Cardiovascular Risk Factor, Obesity

In brief

A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.

Key facts

Study ID

NCT03683134

Run by

Auburn University

People needed

58

Starts

2017-01-23

Expected to finish

2017-09-07

Last updated by the study team

2018-09-27

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in Auburn University's health insurance program during the course of the study or a dependent of the enrollee during the course of the study
• BMI >24.9 (kg/m2)
• AND Meets two or more of the following
• Screening values classified in the "yellow" or "red" zone for:
• Systolic blood pressure (mmHg): Yellow zone: ≥140, Red zone: ≥160;
• Diastolic Blood pressure (mmHg): Yellow zone: ≥90, Red zone: ≥ 100;
• Fasting blood glucose (mm/dL): Yellow zone: ≥100, Red zone: ≥ 126
• Blood glucose (random) (mg/dL): Yellow zone: 140-200, Red zone > 200
• Total Cholesterol (mg/dL): Yellow zone: ≥200, red zone: ≥250
• Have a pre-existing diagnosis of hypertension, pre-diabetes, or hypercholesterolemia
• Current smoker (≥1 cigarette/day)
• Are: male (age: 55-80) or female (age: 60-80)
• A family history of premature coronary heart disease
• High risk ethnicity: Black, African American, American Indians/Alaska Natives, Non-Hispanic blacks, Mexican-Americans, Asian, Hispanic/Latino

You may not qualify if…

• Minors that are less than 19 years of age
• Individuals who are not enrolled in the Auburn University health insurance program for the 2016 plan year at baseline and have not yet completed initial visit
• Individuals who have not completed their 2015 "Healthy Tigers" biometric screening between January 1st and December 31st, 2015 (these can be completed by the "Healthy Tigers" staff or by submitting a healthcare provider form from the individuals' physician to the "Healthy Tigers" office), unless enrolled in "TigerMeds".
• Individuals who are pregnant or who intend to become pregnant during the 12-week health and wellness challenge.
• Individuals who anticipate absence or travel throughout the study that would interfere with their ability to complete the analysis at the mid-point and end of challenge.
• Patients with a peanut, tree nut, or olive oil food allergy or intolerance.
• Patients who are unable or unwilling to travel to Auburn University main campus for live health and wellness challenge events, individual assessments, personal appointments, and pre- and post- data collection
• Individuals who have NOT been stabilized on medication to treat or manage high blood pressure, high cholesterol, dyslipidemia, or pre diabetes for at least 12 weeks prior to the study.
• Patients who do not have access to the internet and therefore unable to complete the education portion of the study
• Individuals who have a pacemaker
• Patients who decline participation during informed consent

Where it is running

• Auburn University Pharmaceutical Care Center — Auburn, Alabama, United States

Full record on ClinicalTrials.gov

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