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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor; Obesity; Cardiovascular Diseases
• Interventions: Behavioral: Mediterranean diet; Behavioral: American Heart Association; Dietary Supplement: Olive oil and mixed nuts

• Registration Number: NCT03683134
• Lead Sponsor: Auburn University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-23
• Primary Completion: 2017-09-07
• Study Completion: 2017-09-07
• Status Verified: 2018-09
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet group	Mediterranean diet	Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.
Mediterranean diet group	Olive oil and mixed nuts	Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.
American Heart Association group	American Heart Association	Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure Measurement	Change from at baseline blood pressure to 12-weeks	Measured in mmHg

Secondary Outcome Measures

Name	Time	Method
Change in Weight	Change from at baseline weight to 12-weeks	Measured in kilograms (kg)
Diastolic Blood Pressure Measurement	Change from at baseline weight to 6-weeks	Measured in mmHg
Calculation of Body Mass Index (BMI) (kg/m∧2)	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)
Calculation of BMI (kg/m∧2)	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)
Concentration of fasted total cholesterol	Change from baseline weight to 12-weeks	Measured in mg/dL
Concentration of fasted low-density lipoprotein (LDL) cholesterol	Change from baseline weight to 6-weeks	Measured in mg/dL
Concentration of fasted blood glucose	Change from baseline weight to 12-weeks	Measured in mg/dL
Concentration of fasted high-density lipoprotein (HDL) cholesterol	Change from baseline weight to 12-weeks	Measured in mg/dL
Concentration of fasted triglycerides	Change from baseline weight to 12-weeks	Measured in mg/dL
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio	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
A calculation of waist (inches) to height (inches) ratio	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
Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin	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.

Trial Locations

Locations (1)

Auburn University Pharmaceutical Care Center; 🇺🇸 Auburn, Alabama, United States