Nuts and Extra Virgin Olive Oil Pilot Study

NCT02831803 | Completed

• 1 other identifier: IRB00028877
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Retention of study participants

  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.

  8 weeks

• Adherence to consuming walnuts and EVOO

  To assess adherence to consuming the nut and oil supplements (measured by daily diary of supplement intake) over the course of the study.

  8 weeks

Secondary Outcomes (4)

• Blood pressure

  8 weeks

• Weight

  8 weeks

• HDL cholesterol

  8 weeks

• Adverse events

  8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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; Dietary Supplement: Extra Virgin Olive Oil

Interventions

Walnuts DIETARY_SUPPLEMENT

28 gm/day in single-serve package

Intervention

Extra Virgin Olive Oil DIETARY_SUPPLEMENT

32 gm/day provided in 3, 34 ounce bottles

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• California Walnut Growers Association: collaborator
• C.H.O. American, Natural and Organic Olive Oil Producer Association: collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mara Z Vitolins, DrPH MPH RDN

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 13, 2016
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2016
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share