The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial

Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.

Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.

Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 and 75 years (since during this age metabolic changes start to take place).

Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout rate.

Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.

Inclusion criteria

• Males and females aged 35-75 years
• Healthy (free of diagnosed diseases listed in exclusion criteria)
• Able to understand the information sheet and willing to comply with study protocol
• Able to give informed consent

Exclusion criteria

• Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
• Body mass index < 20 kg/m2 or > 35 kg/m2
• Plasma cholesterol ≥7.5 mmol/L
• Plasma triacylglycerol > 3 mmol/L
• Plasma glucose > 7 mmol/L
• Blood pressure ≥140/90 mmHg
• Current use of antihypertensive or lipid lowering medications
• Alcohol intake exceeding a moderate intake (> 28 units per week)
• Current cigarette smoker (or quit within the last 6 months)
• ≥ 20% 10-year risk of CVD as calculated using a risk calculator