Clinical trial NCT03438084: The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial
Official title: The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Interesterified
Postprandial
Lipid
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial function
timeFrame: Up to 8 hours
measure: Postprandial lipaemic response
timeFrame: Up to 8 hours
Secondary outcomes:
measure: Postprandial lipaemic response
timeFrame: Up to 8 hours
measure: Metabolomic for assessment of atherogenic potential (lipoprotein) analysis
timeFrame: Up to 8 hours
measure: Glycaemic response
timeFrame: Up to 8 hours
measure: Insulinaemic response
timeFrame: Up to 8 hours
measure: Nitric oxide bioavailability
timeFrame: Up to 8 hours
measure: Oxidative stress
timeFrame: Up to 8 hours
measure: Inflammatory response
timeFrame: Up to 8 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: