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.

• Interesterified fat (Dietary supplement): 50 g fat provided as commercially available interesterified fat.
• Non- interesterified fat (Dietary supplement): 50 g fat provided as commercially available non-interesterified fat.
• Rapeseed oil (Dietary supplement): 50 g fat provided as commercially available rapeseed oil.
• Butter (Dietary supplement): 50g fat provided as commercially available spreadable butter

Primary outcomes

• Endothelial function [Up to 8 hours]: Flow mediated dilatation
• Postprandial lipaemic response [Up to 8 hours]: Area under plasma TAG concentration/ time curve

Secondary outcomes

• Postprandial lipaemic response [Up to 8 hours]: Postprandial plamsa total fatty acid composition and non esterifed fatty acid
• Metabolomic for assessment of atherogenic potential (lipoprotein) analysis [Up to 8 hours]: Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR
• Glycaemic response [Up to 8 hours]: Plasma glucose concentration
• Insulinaemic response [Up to 8 hours]: Plasma insulin concnetration
• Nitric oxide bioavailability [Up to 8 hours]: Plasma nitric oxide species and NADPH oxidase activity
• Oxidative stress [Up to 8 hours]: Plasma 8-isoprostane F2a
• Inflammatory response [Up to 8 hours]: Plasma IL-6

Sex: All, ages: 35 Years to 75 Years, accepts healthy volunteers

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

• Results publication: Hall WL, Alkoblan A, Gibson PS, D'Annibale M, Coekaerts A, Bauer M, Bruce JH, Lecomte B, Penhoat A, Laugerette F, Michalski MC, Salt LJ, Wilde PJ, Berry SE. Postprandial lipid and vascular responses following consumption of a commercially-relevant interesterified palmitic acid-rich spread in comparison to functionally-equivalent non-interesterified spread and spreadable butter: a randomised controlled trial in healthy adults. Food Funct. 2024 Mar 4;15(5):2733-2750. doi: 10.1039/d3fo05324e. PMID 38380649