NCT04867629

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Rapeseed oil	20mL of rapeseed oil to be consumed daily in replacement to habitual oil
DIETARY_SUPPLEMENT	Sunflower oil	20mL of sunflower oil to be consumed daily in replacement to habitual oil

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2021-04-30
• Last updated: 2021-04-30

Locations

1 site across 1 country: United Kingdom