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Completed

NCT Number: NCT02831803

Nuts and Extra Virgin Olive Oil Pilot Study

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

walnuts

Dietary Supplement

28 gm/day in single-serve package

Extra virgin olive oil

Dietary Supplement

32 gm/day provided in 3, 34 ounce bottles

Primary outcomes

  1. Retention of study participants

    Time frame: 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.

  2. Adherence to consuming walnuts and EVOO

    Time frame: 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 outcomes

  1. Blood pressure

    Time frame: 8 weeks

    To estimate the variability of blood pressure in men and women participating in the study

  2. Weight

    Time frame: 8 weeks

    To estimate the variability of weight in men and women participating in the study

  3. HDL cholesterol

    Time frame: 8 weeks

    To estimate the variability of HDL cholesterol in men and women participating in the study

  4. Adverse events

    Time frame: 8 weeks

    To document the types and the rates of adverse events associated with the supplements.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • C.H.O. American, Natural and Organic Olive Oil Producer Association
  • California Walnut Growers Association

Registry information

Official study title

A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Jul 13, 2016
Registry last updated
Aug 1, 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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