Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women
Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to compare changes in cardiovascular function and markers of inflammation and metabolic dysfunction in women randomized to treatment with extra virgin olive oil (EVOO) versus those randomized to treatment with a control oil low in oleic acid and phenols for 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Feb 2019
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedApril 17, 2019
April 1, 2019
1 year
January 23, 2019
April 15, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Arterial pulse wave velocity
Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
8 weeks
Blood pressure
Blood pressure in millimeters mercury (mm Hg).
8 weeks
Arterial distensibility
Arterial distensibility (no units). This is an index of vessel stiffness.
8 weeks
Arterial Beta Stiffness Index
Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
8 weeks
Secondary Outcomes (12)
Flow-mediated vasodilation
8 weeks
Cardiac output
8 weeks
Cardiac output response to volume challenge
8 weeks
C-reactive protein
1 year
High Density Lipoprotein (HDL) Cholesterol
1 year
- +7 more secondary outcomes
Study Arms (2)
Extra Virgin Olive Oil
EXPERIMENTALControl Oil
PLACEBO COMPARATORInterventions
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
Eligibility Criteria
You may qualify if:
- Women are eligible to participate if they are between the ages of 18 and 40, in good health, with regular menstrual cycles and no prior pregnancies.
You may not qualify if:
- Routinely take medications or supplements known to affect blood pressure, heart or blood vessel function, or those with anti-inflammatory or antioxidant properties
- Smoking
- Pregnancy
- Other conditions that would impair adherence, such as allergy to olive oil or sunflower oil or difficulty swallowing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin A Morris, MD
University of Vermont Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Maternal-Fetal Medicine
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 29, 2019
Study Start
February 1, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share