Effect of Olive Oil Consumption on Cardiovascular Biomarkers

Effect of Olive Oil Consumption on Cardiovascular Biomarkers in Asians and Caucasians: A Randomized, Crossover, Controlled Interventional Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Olive oil; Dietary supplement: Butter

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 8ST
    • Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olive oil; Participants will receive 30ml/day of olive oil for two weeks	Dietary supplement: 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.; 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.
Placebo Comparator: Butter; Participants will receive 30g/day of butter also for two weeks.	Dietary supplement: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in ambulatory blood pressure	Baseline and 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in plasma total cholesterol	Plasma total cholesterol vascular cell adhesion molecule 1	Baseline and 2 weeks
Changes in Intercellular Adhesion Molecule 1	Plasma levels of Intercellular Adhesion Molecule 1 measured	Baseline and 2 weeks
Changes in vascular cell adhesion molecule 1	Plasma levels of vascular cell adhesion molecule 1 measured	Baseline and 2 weeks
Changes in C-reactive protein	Plasma levels of CRP measured	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HLS-JLG-OOstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No