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

King's College London

Status: Completed

Conditions: Healthy Adults

Treatments: Dietary Supplement: Butter; Dietary Supplement: Interesterified fat; Dietary Supplement: Rapeseed oil; Dietary Supplement: Non- interesterified fat

Study type: Interventional

Funder types: Other

Identifiers

NCT03438084

HR-

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 4 patient groups

Interesterified

Experimental group

Description:

Commercially available interesterifed fat spread. 50g fat.

Treatment:

Dietary Supplement: Interesterified fat

Non- interesterified

Active Comparator group

Description:

Commercially available non-interesterified fat. 50g fat.

Treatment:

Dietary Supplement: Non- interesterified fat

Control

Active Comparator group

Description:

Rapeseed oil. 50 g fat.

Treatment:

Dietary Supplement: Rapeseed oil

Saturated fat control

Active Comparator group

Description:

Butter. 50g fat

Treatment:

Dietary Supplement: Butter