ClinicalTrials.gg
Status unknownNCT04187638Updated Mar 17, 2020

Effect of Olive Oil Consumption on Cardiovascular Biomarkers

An interventional study of Olive oil and Butter in Cardiovascular Risk Factor, sponsored by Northumbria University. Status unknown at 1 site in United Kingdom. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Northumbria University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2019, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Cardiovascular Risk Factor
03

In context

Lead sponsor

Northumbria University is the lead sponsor of 160 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Olive oil

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

    Dietary Supplement: Olive oil · Dietary Supplement: Butter

  • Placebo comparator
    Butter

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

    Dietary Supplement: Olive oil · Dietary Supplement: Butter

Interventions

  • Dietary supplementOlive 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 supplementButter

    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.

06

What researchers measure

Primary outcomes

  1. changes in ambulatory blood pressure

    Time frame: Baseline and 2 weeks

Secondary outcomes

  1. Changes in plasma total cholesterol

    Plasma total cholesterol vascular cell adhesion molecule 1

    Time frame: Baseline and 2 weeks

  2. Changes in Intercellular Adhesion Molecule 1

    Plasma levels of Intercellular Adhesion Molecule 1 measured

    Time frame: Baseline and 2 weeks

  3. Changes in vascular cell adhesion molecule 1

    Plasma levels of vascular cell adhesion molecule 1 measured

    Time frame: Baseline and 2 weeks

  4. Changes in C-reactive protein

    Plasma levels of CRP measured

    Time frame: Baseline and 2 weeks

07

Study locations

1 site
  • Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
    Newcastle upon Tyne, NE1 8ST, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04187638
Responsible party
Jose Lara Gallegos (Senior Lecturer, Northumbria University) — Principal investigator
First posted
Dec 5, 2019
Start date
Jan 31, 2019
Primary completion
Dec 31, 2019
Completion
Aug 1, 2020 (estimated)
Last update
Mar 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Olive Oil

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