walnuts
Dietary Supplement28 gm/day in single-serve package
NCT Number: NCT02831803
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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Notify Me55 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
28 gm/day in single-serve package
32 gm/day provided in 3, 34 ounce bottles
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.
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.
Time frame: 8 weeks
To estimate the variability of blood pressure in men and women participating in the study
Time frame: 8 weeks
To estimate the variability of weight in men and women participating in the study
Time frame: 8 weeks
To estimate the variability of HDL cholesterol in men and women participating in the study
Time frame: 8 weeks
To document the types and the rates of adverse events associated with the supplements.
Wake Forest University Health Sciences
Other
A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension
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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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