Effect of Olive Oil Consumption on Cardiovascular Biomarkers

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04187638
• Other study ID #: HLS-JLG-OOstudy
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: March 2020
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in ambulatory blood pressure		Baseline and 2 weeks
Secondary	Changes in plasma total cholesterol	Plasma total cholesterol vascular cell adhesion molecule 1	Baseline and 2 weeks
Secondary	Changes in Intercellular Adhesion Molecule 1	Plasma levels of Intercellular Adhesion Molecule 1 measured	Baseline and 2 weeks
Secondary	Changes in vascular cell adhesion molecule 1	Plasma levels of vascular cell adhesion molecule 1 measured	Baseline and 2 weeks
Secondary	Changes in C-reactive protein	Plasma levels of CRP measured	Baseline and 2 weeks