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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Adults

Intervention / Treatment
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* Dietary Supplement: Interesterified fat
* Dietary Supplement: Non- interesterified fat
* Dietary Supplement: Rapeseed oil
* Dietary Supplement: Butter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interesterified<br>Commercially available interesterifed fat spread. 50g fat. | Dietary Supplement: Interesterified fat<br>* 50 g fat provided as commercially available interesterified fat.<br>|
| Active Comparator: Non- interesterified<br>Commercially available non-interesterified fat. 50g fat. | Dietary Supplement: Non- interesterified fat<br>* 50 g fat provided as commercially available non-interesterified fat.<br>|
| Active Comparator: Control<br>Rapeseed oil. 50 g fat. | Dietary Supplement: Rapeseed oil<br>* 50 g fat provided as commercially available rapeseed oil.<br>|
| Active Comparator: Saturated fat control<br>Butter. 50g fat | Dietary Supplement: Butter<br>* 50g fat provided as commercially available spreadable butter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow mediated dilatation | Up to 8 hours | 
| Postprandial lipaemic response | Area under plasma TAG concentration/ time curve | Up to 8 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interesterified, Postprandial, Lipid