Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-02 @ 6:44 AM
Study NCT ID:
NCT02831803
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nuts and Extra Virgin Olive Oil Pilot Study
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: