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

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.

Conditions

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Obesity

Interventions

BEHAVIORAL

Mediterranean diet

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.

DIETARY_SUPPLEMENT

Olive oil and mixed nuts

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.

BEHAVIORAL

American Heart Association

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.

Sponsors & Collaborators

• Auburn University

  lead OTHER

Principal Investigators

• Michael W Greene, PhD · Auburn University

• Amy W Willis, MS, RD · Auburn University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-23

Primary Completion

2017-09-07

Completion

2017-09-07

Countries

• United States

Study Locations