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

Study Overview
=================
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

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

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Rapeseed oil
* Dietary Supplement: Sunflower oil


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blind, placebo-controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapeseed oil<br>Participants asked to consume 20mL of rapeseed oil raw every day for 12 weeks | Dietary Supplement: Rapeseed oil<br>* 20mL of rapeseed oil to be consumed daily in replacement to habitual oil<br>* Other names: RO;|
| Active Comparator: Sunflower oil<br>Participants asked to consume 20mL of sunflower oil raw every day for 12 weeks | Dietary Supplement: Sunflower oil<br>* 20mL of sunflower oil to be consumed daily in replacement to habitual oil<br>* Other names: SO;|
| No Intervention: Habitual diet<br>Participants asked to maintain their habitual diet for 12 weeks | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic biomarkers | Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273) | 0, 6, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 0, 6, 12 weeks | 
| Oxidative stress biomarkers | Changes in concentrations of plasma fructosamine, AGE, RAGE | 0, 6, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiometabolic, rapeseed oil, sunflower oil, proteomics, cardiovascular, fatty acids, monounsaturated fatty acids, seed oils, dietary fat