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Completed

NCT Number: NCT04867629

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

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow

Glasgow, Scotland, G12 8QE, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapeseed oil

Dietary Supplement

20mL of rapeseed oil to be consumed daily in replacement to habitual oil

Other names: RO

Sunflower oil

Dietary Supplement

20mL of sunflower oil to be consumed daily in replacement to habitual oil

Other names: SO

Primary outcomes

  1. Proteomic biomarkers

    Time frame: 0, 6, 12 weeks

    Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)

Secondary outcomes

  1. Blood lipids

    Time frame: 0, 6, 12 weeks

    Changes in concentrations of plasma glucose, triglycerides, total cholesterol, high density lipoprotein,

  2. Inflammation markers

    Time frame: 0, 6, 12 weeks

    Changes in concentrations of plasma interleukin 6, tumor necrosis factor, matrix metallopeptidase 9

  3. Oxidative stress biomarkers

    Time frame: 0, 6, 12 weeks

    Changes in concentrations of plasma fructosamine, AGE, RAGE

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Official study 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

Acronym: DOC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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