Nuts and Extra Virgin Olive Oil Pilot Study

Wake Forest University (WFU)

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Extra Virgin Olive Oil; Dietary Supplement: Walnuts

Study type: Interventional

Funder types: Other

Identifiers

NCT02831803

IRB00028877

Details and patient eligibility

About

This study is designed to test the feasibility of asking older adults with high blood pressure to supplement their daily diets with walnuts and extra-virgin olive oil.

Full description

Even though cardiovascular disease (CVD) continues to be the leading cause of death in the United States, Americans have yet to widely adopt evidence-based dietary modifications necessary to reduce CVD risk factors. Encouraging evidence from the Prevención con Dieta Mediterránea (PREDIMED) trial indicates that adding olive oil and nuts to the diets of older adults in Spain substantially impacted CVD risk factors and events.

A large trial testing EVOO and nuts in a U.S. population is needed to determine if supplementing with EVOO and nuts can reduce risk of cardiovascular events and mortality in adults living in the U.S. Prior to launching a large trial, it is important to assess whether adults 55 and older would be interested in participating in a supplementation trial such as PREDIMED. Additionally, it is important to assess if they are willing to consume the nuts and EVOO and attend study related-data collection visits.

Enrollment: 27 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being treated for hypertension-defined by being prescribed at least one hypertension medication; willing to comply with study visits, as outlined in the protocol; able to read and speak English; no allergies or hypersensitivities to olive oil or nuts; ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Plans to move from the study area in the next 8 weeks; dementia that is medically documented or suspected; homebound for medical reasons; cancer diagnosis and/or treatment in the last 3 years.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Intervention

Experimental group

Description:

All participants will receive an 8-week supply of walnuts and Extra Virgin Olive Oil (EVOO). Study supplements will consist of 28 gm of walnuts and 32 gm of EVOO per day. Participants will be instructed how to consume the proper amount of walnuts and EVOO and to report their consumption using a compliance diary. The walnuts are pre-packaged in daily servings (one 28 g packet per day) and measuring spoons will be provided with the olive oil to assist participants in consuming it appropriately. Participants will also receive recipes and other written information that will assist them in incorporating both the nuts and olive oil into their existing dietary patterns.

Treatment:

Dietary Supplement: Walnuts

Dietary Supplement: Extra Virgin Olive Oil