Effect of Olive Oil Consumption on Cardiovascular Biomarkers

NCT04187638 | Unknown

• 1 other identifier: HLS-JLG-OOstudy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• changes in ambulatory blood pressure

  Baseline and 2 weeks

Secondary Outcomes (4)

• Changes in plasma total cholesterol

  Baseline and 2 weeks

• Changes in Intercellular Adhesion Molecule 1

  Baseline and 2 weeks

• Changes in vascular cell adhesion molecule 1

  Baseline and 2 weeks

• Changes in C-reactive protein

  Baseline and 2 weeks

Study Arms (2)

Olive oil

EXPERIMENTAL

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

Dietary Supplement: Olive oil; Dietary Supplement: Butter

Butter

PLACEBO COMPARATOR

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

Dietary Supplement: Olive oil; Dietary Supplement: Butter

Interventions

Olive oil 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; Olive oil

Butter 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; Olive oil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Orient Asians (including Chinese, Japanese, Korean, and Malaysia Chinese) and Caucasians
• Age 18-70 years
• Self-reported in good general health

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

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

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Olive Oil; Butter

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dairy Products

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: A randomized, double-blind, placebo-controlled crossover trial.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 5, 2019
• Study Start: January 31, 2019
• Primary Completion: December 31, 2019
• Study Completion: August 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)