Nuts and Extra Virgin Olive Oil Pilot Study

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Walnuts; Dietary Supplement: Extra Virgin Olive Oil

• Registration Number: NCT02831803
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2014-12
• Study Completion: 2016-01
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Extra Virgin Olive Oil	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.
Intervention	Walnuts	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.

Primary Outcome Measures

Name	Time	Method
Retention of study participants	8 weeks	To estimate retention (measured by number attending the 8 week closeout visit) of men and women being treated for hypertension in the 8 week study.
Adherence to consuming walnuts and EVOO	8 weeks	To assess adherence to consuming the nut and oil supplements (measured by daily diary of supplement intake) over the course of the study.

Secondary Outcome Measures

Name	Time	Method
HDL cholesterol	8 weeks	To estimate the variability of HDL cholesterol in men and women participating in the study
Blood pressure	8 weeks	To estimate the variability of blood pressure in men and women participating in the study
Weight	8 weeks	To estimate the variability of weight in men and women participating in the study
Adverse events	8 weeks	To document the types and the rates of adverse events associated with the supplements.