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

The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular

The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.

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