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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapeseed oil | Experimental | Participants asked to consume 20mL of rapeseed oil raw every day for 12 weeks |
|
| Sunflower oil | Active Comparator | Participants asked to consume 20mL of sunflower oil raw every day for 12 weeks |
|
| Habitual diet | No Intervention | Participants asked to maintain their habitual diet for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapeseed oil | Dietary Supplement | 20mL of rapeseed oil to be consumed daily in replacement to habitual oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic biomarkers | Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273) | 0, 6, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids | Changes in concentrations of plasma glucose, triglycerides, total cholesterol, high density lipoprotein, | 0, 6, 12 weeks |
| Inflammation markers | Changes in concentrations of plasma interleukin 6, tumor necrosis factor, matrix metallopeptidase 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Glasgow | Glasgow | Scotland | G12 8QE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35381848 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000074262 | Rapeseed Oil |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 |
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A randomized, double-blind, placebo-controlled trial
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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
| Sunflower oil | Dietary Supplement | 20mL of sunflower oil to be consumed daily in replacement to habitual oil |
|
|
| 0, 6, 12 weeks |
| Oxidative stress biomarkers | Changes in concentrations of plasma fructosamine, AGE, RAGE | 0, 6, 12 weeks |
| Biological Products |
| D045424 | Complex Mixtures |