Effect of Olive Oil Consumption on Cardiovascular Biomarkers

Sponsor

Northumbria University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04187638

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factor	Dietary Supplement: Olive oil Dietary Supplement: Butter	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A randomized, double-blind, placebo-controlled crossover trial.A randomized, double-blind, placebo-controlled crossover trial.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 31, 2019

Actual Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

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.

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

Placebo Comparator: Butter

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

Dietary Supplement: Olive oil

Dietary Supplement: Butter

Outcome Measures

Primary Outcome Measures

changes in ambulatory blood pressure [Baseline and 2 weeks]

Secondary Outcome Measures

Changes in plasma total cholesterol [Baseline and 2 weeks]
Plasma total cholesterol vascular cell adhesion molecule 1
Changes in Intercellular Adhesion Molecule 1 [Baseline and 2 weeks]
Plasma levels of Intercellular Adhesion Molecule 1 measured
Changes in vascular cell adhesion molecule 1 [Baseline and 2 weeks]
Plasma levels of vascular cell adhesion molecule 1 measured
Changes in C-reactive protein [Baseline and 2 weeks]
Plasma levels of CRP measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University	Newcastle upon Tyne		United Kingdom	NE1 8ST

Sponsors and Collaborators

Northumbria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Lara Gallegos, Senior Lecturer, Northumbria University

ClinicalTrials.gov Identifier:

NCT04187638

Other Study ID Numbers:

HLS-JLG-OOstudy

First Posted:

Dec 5, 2019

Last Update Posted:

Mar 17, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 17, 2020