Clinical trial NCT04867629: Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: rapeseed oil
sunflower oil
proteomics
cardiometabolic
cardiovascular
fatty acids
monounsaturated fatty acids
seed oils
dietary fat
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 84
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled trial
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Proteomic biomarkers
timeFrame: 0, 6, 12 weeks
Secondary outcomes:
measure: Blood lipids
timeFrame: 0, 6, 12 weeks
measure: Inflammation markers
timeFrame: 0, 6, 12 weeks
measure: Oxidative stress biomarkers
timeFrame: 0, 6, 12 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
state: Scotland
Study officials:
References:
citation: Nicol K, Mansoorian B, Latosinska A, Koutroulaki A, Mullen B, Combet E. No evidence of differential impact of sunflower and rapeseed oil on biomarkers of coronary artery disease or chronic kidney disease in healthy adults with overweight and obesity: result from a randomised control trial. Eur J Nutr. 2022 Sep;61(6):3119-3133. doi: 10.1007/s00394-022-02810-5. Epub 2022 Apr 5.