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Nuts and Extra Virgin Olive Oil Pilot Study

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ClinicalTrials.gov Identifier: NCT02831803
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Dietary Supplement: Walnuts Dietary Supplement: 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension
Study Start Date : October 2014
Primary Completion Date : December 2014
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
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.
Dietary Supplement: Walnuts
28 gm/day in single-serve package
Dietary Supplement: Extra Virgin Olive Oil
32 gm/day provided in 3, 34 ounce bottles


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831803


Sponsors and Collaborators
Wake Forest University Health Sciences
California Walnut Growers Association
C.H.O. American, Natural and Organic Olive Oil Producer Association
Investigators
Principal Investigator: Mara Z Vitolins, DrPH MPH RDN Wake Forest University Health Sciences
More Information

Responsible Party: Mara Z. Vitolins, Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02831803     History of Changes
Other Study ID Numbers: IRB00028877
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases