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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Sunflower oil; Dietary Supplement: Rapeseed oil

• Registration Number: NCT04867629
• Lead Sponsor: University of Glasgow

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2021-04
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunflower oil	Sunflower oil	Participants asked to consume 20mL of sunflower oil raw every day for 12 weeks
Rapeseed oil	Rapeseed oil	Participants asked to consume 20mL of rapeseed oil raw every day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proteomic biomarkers	0, 6, 12 weeks	Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)

Secondary Outcome Measures

Name	Time	Method
Blood lipids	0, 6, 12 weeks	Changes in concentrations of plasma glucose, triglycerides, total cholesterol, high density lipoprotein,
Inflammation markers	0, 6, 12 weeks	Changes in concentrations of plasma interleukin 6, tumor necrosis factor, matrix metallopeptidase 9
Oxidative stress biomarkers	0, 6, 12 weeks	Changes in concentrations of plasma fructosamine, AGE, RAGE

Trial Locations

Locations (1)

University of Glasgow; 🇬🇧 Glasgow, Scotland, United Kingdom