Effect of Olive Oil Consumption on Cardiovascular Biomarkers

NCT ID: NCT04187638

Last Updated: 2020-03-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-08-01

Brief Summary

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The main aim of this study is to examine the effect of olive oil consumption on several cardiovascular risk markers between Caucasians and Asian ethnicity. The primary assessments: endothelial function's biomarkers: cell and vascular adhesion molecules (ICAMs and VCAMs) and nitric oxide (NO). The secondary assessments: Lipid profile.

Detailed Description

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Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomized, double-blind, placebo-controlled crossover trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Olive oil

Participants will receive 30ml/day of olive oil for two weeks

Group Type EXPERIMENTAL

Olive oil

Intervention Type DIETARY_SUPPLEMENT

Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.

Butter

Intervention Type DIETARY_SUPPLEMENT

Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.

Butter

Participants will receive 30g/day of butter also for two weeks.

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type DIETARY_SUPPLEMENT

Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.

Butter

Intervention Type DIETARY_SUPPLEMENT

Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.

Interventions

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Olive oil

Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.

Intervention Type DIETARY_SUPPLEMENT

Butter

Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Male

Orient Asians (including Chinese, Japanese, Korean, and Malaysia Chinese) and Caucasians

Age 18-70 years

Self-reported in good general health

Exclusion Criteria

Female

Age older than 70 years or younger than 18 years

Diagnosed and/or are taking medications for hypertension (\>140/90mmHg)

Diabetes

High blood cholesterol

Heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome)

Allergy to olive oil or olive oil products

Lactose intolerance

Taking omega-3 supplements in fish oil and vitamins supplements in the last six months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Jose Lara Gallegos

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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HLS-JLG-OOstudy

Identifier Type: -

Identifier Source: org_study_id

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