Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases.

Cardiovascular Diseases Clinical Trial

— DOC  

Official title:

No Evidence of Impact of Seed Oil Intake on Biomarkers of Coronary Artery Disease, Chronic Kidney Disease and Diabetes in Healthy Adults With Overweight and Obesity - Result From a Blinded Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867629
• Other study ID #: DOC
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2021
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the impact of vegetable oils with contrasting fatty acids composition on biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs, locally produced) and a non-intervention control. We have developed a sensitive and selective urinary proteomic biomarker of cardiovascular disease which we will use in a double-blinded randomised study.

Description:

The intervention follows a parallel double-blind randomised control design. The intervention duration is 12 weeks, with a mid-point assessment at 6 weeks. Randomisation to groups; rapeseed oil, sunflower oil or habitual diet is performed using a block stratified allocation based on age (under or over 45) and BMI (under or over 30kg/m2) and is carried out remotely via phone.

Participants allocated to either oil groups are instructed to consume the oils uncooked, as a partial replacement to their habitual fat intake. Participants in the control group are asked to not change any aspect of their diet.

Spot urine samples are collected from all participants at all time points for measurement of the primary outcome (proteomic biomarker score). Urine is collected in a plastic tube, mid-flow, as the second urination of the day at baseline, 6 and 12 weeks.

Fasting venous blood is collected for the assessment of secondary outcomes, at baseline, 6 weeks and 12 weeks. Participants are also asked to complete a 2-day food diary at weeks 0, 6 and 12

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Overweight adults with a BMI>25 and/or a large waist (Male >102cm and female >88cm),

• Aged 25-75 years

• No history of chronic disease of the GI tract

• Not taking medication (other than the contraceptive pill).

Exclusion Criteria:

• Pregnant or lactating

• Allergy to any vegetable oils and vegetable oil-derived products

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Rapeseed oil
20mL of rapeseed oil to be consumed daily in replacement to habitual oil
• Sunflower oil
20mL of sunflower oil to be consumed daily in replacement to habitual oil

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic biomarkers	Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)	0, 6, 12 weeks
Secondary	Blood lipids	Changes in concentrations of plasma glucose, triglycerides, total cholesterol, high density lipoprotein,	0, 6, 12 weeks
Secondary	Inflammation markers	Changes in concentrations of plasma interleukin 6, tumor necrosis factor, matrix metallopeptidase 9	0, 6, 12 weeks
Secondary	Oxidative stress biomarkers	Changes in concentrations of plasma fructosamine, AGE, RAGE	0, 6, 12 weeks