Cardiovascular Diseases
Conditions
Keywords
rapeseed oil, sunflower oil, proteomics, cardiometabolic, cardiovascular, fatty acids, monounsaturated fatty acids, seed oils, dietary fat
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
Interventions
DIETARY_SUPPLEMENTRapeseed oil
20mL of rapeseed oil to be consumed daily in replacement to habitual oil
DIETARY_SUPPLEMENTSunflower oil
20mL of sunflower oil to be consumed daily in replacement to habitual oil
Sponsors
University of Glasgow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Oils were in identical amber glass bottles labelled A or B. Oils blinded to participants and investigators. However, the control group was unblinded due to them not receiving any intervention
Intervention model description
A randomized, double-blind, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proteomic biomarkers | 0, 6, 12 weeks | Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed