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OpenTrials
Completed

NCT Number: NCT03683134

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University Pharmaceutical Care Center

Auburn, Alabama, 36849, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mediterranean Diet

Behavioral

Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.

Olive oil and mixed nuts

Dietary Supplement

Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.

American Heart Association

Behavioral

Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.

Primary outcomes

  1. Systolic Blood Pressure Measurement

    Time frame: Change from at baseline blood pressure to 6-weeks

    Measured in mmHg

  2. Systolic Blood Pressure Measurement

    Time frame: Change from at baseline blood pressure to 12-weeks

    Measured in mmHg

Secondary outcomes

  1. Diastolic Blood Pressure Measurement

    Time frame: Change from at baseline weight to 6-weeks

    Measured in mmHg

  2. Change in Weight

    Time frame: Change from at baseline weight to 12-weeks

    Measured in kilograms (kg)

  3. Calculation of Body Mass Index (BMI) (kg/m∧2)

    Time frame: Change from baseline weight to 6-weeks

    Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)

  4. Calculation of BMI (kg/m∧2)

    Time frame: Change from baseline weight to 12-weeks

    Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)

  5. Concentration of fasted total cholesterol

    Time frame: Change from baseline weight to 6-weeks

    Measured in mg/dL

  6. Concentration of fasted total cholesterol

    Time frame: Change from baseline weight to 12-weeks

    Measured in mg/dL

  7. Concentration of fasted high-density lipoprotein (HDL) cholesterol

    Time frame: Change from baseline weight to 6-weeks

    Measured in mg/dL

  8. Concentration of fasted high-density lipoprotein (HDL) cholesterol

    Time frame: Change from baseline weight to 12-weeks

    Measured in mg/dL

  9. Concentration of fasted low-density lipoprotein (LDL) cholesterol

    Time frame: Change from baseline weight to 12-weeks

    Measured in mg/dL

  10. Concentration of fasted low-density lipoprotein (LDL) cholesterol

    Time frame: Change from baseline weight to 6-weeks

    Measured in mg/dL

  11. Concentration of fasted triglycerides

    Time frame: Change from baseline weight to 6-weeks

    Measured in mg/dL

  12. Concentration of fasted triglycerides

    Time frame: Change from baseline weight to 12-weeks

    Measured in mg/dL

  13. A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio

    Time frame: Change from baseline weight to 12-weeks

    Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio

  14. A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio

    Time frame: Change from baseline weight to 6-weeks

    Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio

  15. Concentration of fasted blood glucose

    Time frame: Change from baseline weight to 6-weeks

    Measured in mg/dL

  16. Concentration of fasted blood glucose

    Time frame: Change from baseline weight to 12-weeks

    Measured in mg/dL

  17. A calculation of waist (inches) to height (inches) ratio

    Time frame: Change from baseline weight to 12-weeks

    Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio

  18. A calculation of waist (inches) to height (inches) ratio

    Time frame: Change from baseline weight to 6-weeks

    Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio

  19. Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin

    Time frame: Change from baseline weight to 6-weeks

    Fasting plasma glucose in mg/dL and fasting serum insulin in milliUnits (mU)/I will be used to calculate HOMA-IR as an indicator for insulin resistance.

  20. Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin

    Time frame: Change from baseline weight to 12-weeks

    Fasting plasma glucose in mg/dL and fasting serum insulin in mU/I will be used to calculate HOMA-IR as an indicator for insulin resistance.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

A Pilot, Theory-Based, Nutrition Intervention Promoting a Mediterranean Diet for the Reduction of Cardiovascular Disease Risk Factors in a High-Risk Population of the Southeastern United States: The Healthy Hearts Program (HHP)

Acronym: HHP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2018
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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