Hypertension
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWalnuts
28 gm/day in single-serve package
DIETARY_SUPPLEMENTExtra Virgin Olive Oil
32 gm/day provided in 3, 34 ounce bottles
Sponsors
California Walnut Growers Association
C.H.O. American, Natural and Organic Olive Oil Producer Association
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| HDL cholesterol | 8 weeks | To estimate the variability of HDL cholesterol 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. |
Outcome results
None listed