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Cardiovascular DiseaseNCT01983943

Olive Oil and Cardiovascular Health

A study testing Hydroxytyrosol, the active ingredient in olive oil., Nutrition counseling and Endopat in people with Cardiovascular Disease and Endothelial Function, run by Mayo Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Disease, Endothelial Function
What is being tested?
Hydroxytyrosol, the active ingredient in olive oil., Nutrition counseling and Endopat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2013to Jul 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Subjects will be included if they have all of the following

  1. Age ≥ 18 years old
  2. Have known diagnosis of coronary artery disease
  3. Demonstrated endothelial dysfunction (reactive hyperemia - EndoPAT score < 2.0) at time of screening

Patient exclusion criteria:

Patients will be excluded if they have one or more of the following:

  1. Hypertension (at Screening): any patient with systolic blood pressure (SBP) ≥ 170 mmHg or diastolic blood pressure ≥ 110 mmHg, or hypotension (SBP < 100 mmHg)
  2. Uncontrolled Diabetes Mellitus
  3. Experienced an acute coronary syndrome within 3 months
  4. PCI or revascularization for an acute coronary syndrome within 3 months
  5. Second (II) or third (III) degree heart block without a pacemaker and/or concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia
  6. Congestive heart failure NYHA class III and IV
  7. Unstable serum creatinine (>2.0)
  8. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the olive oil including, but not limited to, any of the following:
  • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
  • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
  • Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt
  1. Any concurrent life threatening condition with a life expectancy less than 2 years
  2. History or evidence of drug or alcohol abuse within the last 12 months
  3. History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
  4. History of noncompliance to medical regimens or unwillingness to comply with the study protocol
  5. History of malignancy other than basal cell skin cancer within the past five years
  6. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
  7. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  8. Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety
  9. Persons directly involved in the execution of this protocol
  10. Pregnant or nursing (lactating) women
  11. Women of child-bearing potential unless postmenopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Effects of Hydroxytyrosol on Vascular Health

The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI).

Being tested
Hydroxytyrosol, the active ingredient in olive oil., Placebo, Nutrition counseling, Endopat
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydroxytyrosol, the active ingredient in olive oil.Dietary supplement

    A 40mg capsule will be taken once daily for 6 months.

  • PlaceboDietary supplement

    A 40mg placebo will be taken once per day for 6 months.

  • Nutrition counselingBehavioural

    Nutrition counseling on eating a healthy diet will be offered once at baseline.

  • EndopatDevice

    An endopat test will be administered twice, once and baseline and once after 6 months of supplementation, to test endothelial function. This is a non-invasive test that takes about 15 minutes.

Study groups in NCT01983943
Study groupRoleWhat they receive
HydroxytyrosolExperimentalHydroxytyrosol, the major polyphenol in olive oil, 40mg will be taken once per day for 6 months.
Receives: Dietary Supplement: Hydroxytyrosol, the active ingredient in olive oil.; Behavioral: Nutrition counseling; Device: Endopat
PlaceboPlacebo comparatorPlacebo 40mg will be taken once per day for 6 months.
Receives: Dietary Supplement: Placebo; Behavioral: Nutrition counseling; Device: Endopat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial function

    In order to address these hypotheses, our specific aims are to investigate the effect of administration of six months of hydroxytyrosol in individuals with multiple cardiovascular risk factors and with known coronary artery disease, on: Improvement of endothelial function as determined by peripheral endothelial function testing and circulating EPCs.

    Measured: 6 months

  2. Surrogate markers

    In order to address these hypotheses, our specific aims are to investigate the effect of administration of six months of hydroxytyrosol in individuals with multiple cardiovascular risk factors and with known coronary artery disease, on: Improvement and normalization of surrogate markers of CVD such as leukocytes, glucose, lipids, renal function, and high-sensitivity C-reactive protein (hs-CRP).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Why it stopped: No participants were enrolled

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01983943
Sponsor's protocol ID
13-001080
Status last verified
Jun 2015
First submitted
7 Nov 2013
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Hydroxytyrosol, the active ingredient in olive oil., Nutrition counseling and Endopat in people with Cardiovascular Disease and Endothelial Function, run by Mayo Clinic 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?

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: withdrawn, as of the sponsor's last update on 3 Jun 2015. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial function (time frame: 6 months). The study lists 2 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 3 Jun 2015.

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