The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial
- Conditions
- Healthy Adults
- Interventions
- Dietary Supplement: ButterDietary Supplement: Rapeseed oilDietary Supplement: Interesterified fatDietary Supplement: Non- interesterified fat
- Registration Number
- NCT03438084
- Lead Sponsor
- King's College London
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Saturated fat control Butter Butter. 50g fat Control Rapeseed oil Rapeseed oil. 50 g fat. Interesterified Interesterified fat Commercially available interesterifed fat spread. 50g fat. Non- interesterified Non- interesterified fat Commercially available non-interesterified fat. 50g fat.
- Primary Outcome Measures
Name Time Method Endothelial function Up to 8 hours Flow mediated dilatation
Postprandial lipaemic response Up to 8 hours Area under plasma TAG concentration/ time curve
- Secondary Outcome Measures
Name Time Method 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
Inflammatory response Up to 8 hours Plasma IL-6
Oxidative stress Up to 8 hours Plasma 8-isoprostane F2a
Trial Locations
- Locations (2)
King's College London
🇬🇧London, United Kingdom
Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London
🇬🇧London, United Kingdom