A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 27
- Primary Endpoint
- Retention of study participants
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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.
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
- HDL cholesterol(8 weeks)
- Blood pressure(8 weeks)
- Weight(8 weeks)
- Adverse events(8 weeks)