Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function

NCT ID: NCT00865787

Last Updated: 2011-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-04-30

Brief Summary

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This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a daily diet will improve endothelial function.

Detailed Description

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Patients will be randomized to receive either placebo ROO (refined olive oil) or study solution EGCG-EVOO (EGCG enhanced extra-virgin olive oil) over the four month study period.

Conditions

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Atherosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Olive Oil A

No interventions assigned to this group

Olive Oil B

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients will be included in the study if they have an abnormal endothelial function study. This is defined at our institution as an RH-PAT index of less than 2. Patients will undergo two RH-PAT analyses and included abnormal values are obtained on either one or both tests. Only patients who provide written informed consent will be included.

Exclusion Criteria

* Patients with normal baseline endothelial function studies defined as RH-PAT index \>2 will be excluded. Patients with uncontrolled hypertension \>180/100 while on medication on initial evaluation will also be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Olivi Agri Team Srl- Grosetto, Italy

UNKNOWN

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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St Marys Hospital

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Widmer RJ, Freund MA, Flammer AJ, Sexton J, Lennon R, Romani A, Mulinacci N, Vinceri FF, Lerman LO, Lerman A. Beneficial effects of polyphenol-rich olive oil in patients with early atherosclerosis. Eur J Nutr. 2013 Apr;52(3):1223-31. doi: 10.1007/s00394-012-0433-2. Epub 2012 Aug 8.

Reference Type DERIVED
PMID: 22872323 (View on PubMed)

Other Identifiers

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07-002656

Identifier Type: -

Identifier Source: org_study_id

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