HypertensionNCT03820336
Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women
A study testing Extra Virgin Olive Oil in people with Hypertension and Vascular Stiffness, run by University of Vermont Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Vascular Stiffness
- What is being tested?
- Extra Virgin Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Erin A Morris, MD, 802-847-0408, erin.morris@uvmhealth.org
About this study
Official title: Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
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.
Read the detailed description
Participants will be randomized to receive 45 ml (40 g) of extra virgin olive oil (EVOO) daily for 8 weeks or an identical dose of a control sunflower seed oil low in oleic acid and phenol content. EVOO high in oleic acid and phenolic content will be identified and shipped from Italy and stored protected from heat and light in the Bionutrition Core at the Clinical Research Center at the University of Vermont Medical Center. Women will undergo a detailed cardiovascular assessment at baseline and following treatment, including assessment of blood pressure, pulse-wave velocity, calculation of arterial distensibility and beta stiffness, flow-mediated vasodilation, cardiac output, response to volume challenge and dual-energy X-ray absorptiometry (DEXA). Lipid profiles and markers of inflammation, oxidative stress and metabolic dysfunction will also be assessed at both study visits.
Investigators hypothesize that treatment with high oleic acid and phenolic EVOO will be associated with decreased blood pressure, improved vascular compliance and blood vessel function, and with improvement in lipid profile, inflammation and markers of metabolic dysfunction.
- Conditions
- Hypertension, Vascular Stiffness
- Being tested
- Extra Virgin Olive Oil, Control Oil
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra Virgin Olive OilDietary supplement
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
Control OilDietary supplement
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Extra Virgin Olive Oil | Experimental | Not described Receives: Dietary Supplement: Extra Virgin Olive Oil |
| Control Oil | Placebo comparator | Not described Receives: Dietary Supplement: Control Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial pulse wave velocity
Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
Measured: 8 weeks
Blood pressure
Blood pressure in millimeters mercury (mm Hg).
Measured: 8 weeks
Arterial distensibility
Arterial distensibility (no units). This is an index of vessel stiffness.
Measured: 8 weeks
Arterial Beta Stiffness Index
Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
Measured: 8 weeks
Secondary outcomes (12)
Flow-mediated vasodilation
Flow-mediated vasodilation in percent. This is a measure of endothelial health.
Measured: 8 weeks
Cardiac output
Cardiac output in liters per minute.
Measured: 8 weeks
Cardiac output response to volume challenge
Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.
Measured: 8 weeks
C-reactive protein
Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.
Measured: 1 year
High Density Lipoprotein (HDL) Cholesterol
Serum high density lipoprotein in milligrams/deciliter.
Measured: 1 year
Low Density Lipoprotein (LDL) Cholesterol
Serum low density lipoprotein in milligrams/deciliter.
Measured: 1 year
Triglycerides
Serum triglycerides in milligrams/deciliter.
Measured: 1 year
Insulin
Fasting serum insulin level in micro international units per milliliter (µIU/mL).
Measured: 1 year
Hemoglobin A1C
Serum hemoglobin A1C in percent.
Measured: 1 year
B-type natriuretic peptide (BNP)
B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.
Measured: 1 year
Interleukin 6 (IL-6)
Interleukin 6 in picograms per milliliter. This is a measure of inflammation.
Measured: 1 year
Tumor necrosis factor alpha (TNF-α)
Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Morris, University of Vermont Medical Center
- Investigators
- Erin A Morris, MD, Principal investigator, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820336
- Sponsor's protocol ID
- 18-0639
- Status last verified
- Apr 2019
- First submitted
- 23 Jan 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03820336
- Acronym / sponsor ID
- 18-0639
- Conditions
- Hypertension, Vascular Stiffness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomized to receive 45 ml (40 g) of extra virgin olive oil (EVOO) daily for 8 weeks or an identical dose of a control sunflower seed oil low in oleic acid and phenol content. EVOO high in oleic acid and phenolic content will be identified and shipped from Italy and stored protected from heat and light in the Bionutrition Core at the Clinical Research Center at the University of Vermont Medical Center. Women will undergo a detailed cardiovascular assessment at baseline and following treatment, including assessment of blood pressure, pulse-wave velocity, calculation of arterial distensibility and beta stiffness, flow-mediated vasodilation, cardiac output, response to volume challenge and dual-energy X-ray absorptiometry (DEXA). Lipid profiles and markers of inflammation, oxidative stress and metabolic dysfunction will also be assessed at both study visits.
Investigators hypothesize that treatment with high oleic acid and phenolic EVOO will be associated with decreased blood pressure, improved vascular compliance and blood vessel function, and with improvement in lipid profile, inflammation and markers of metabolic dysfunction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra Virgin Olive Oil | Experimental | Dietary Supplement: Extra Virgin Olive Oil |
| Control Oil | Placebo comparator | Dietary Supplement: Control Oil |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra Virgin Olive OilSubjects will consume 45 ml (40 g) of EVOO daily for 8 weeks. | Dietary supplement | Extra Virgin Olive Oil |
| Control OilSubjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks. | Dietary supplement | Control Oil |
Primary outcome
Arterial pulse wave velocity
Time frame: 8 weeks
Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
Blood pressure
Time frame: 8 weeks
Blood pressure in millimeters mercury (mm Hg).
Arterial distensibility
Time frame: 8 weeks
Arterial distensibility (no units). This is an index of vessel stiffness.
Arterial Beta Stiffness Index
Time frame: 8 weeks
Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
12 secondary outcomes
Flow-mediated vasodilation
Time frame: 8 weeks
Cardiac output
Time frame: 8 weeks
Cardiac output response to volume challenge
Time frame: 8 weeks
C-reactive protein
Time frame: 1 year
High Density Lipoprotein (HDL) Cholesterol
Time frame: 1 year
Low Density Lipoprotein (LDL) Cholesterol
Time frame: 1 year
Triglycerides
Time frame: 1 year
Insulin
Time frame: 1 year
Hemoglobin A1C
Time frame: 1 year
B-type natriuretic peptide (BNP)
Time frame: 1 year
Interleukin 6 (IL-6)
Time frame: 1 year
Tumor necrosis factor alpha (TNF-α)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin A Morris, MD principal investigator
University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra Virgin Olive Oil in people with Hypertension and Vascular Stiffness, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Morris, MD ((802) 847-0408, erin.morris@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial pulse wave velocity (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.