The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial
NCT ID: NCT03438084
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-07-01
2019-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Interesterified
Commercially available interesterifed fat spread. 50g fat.
Interesterified fat
50 g fat provided as commercially available interesterified fat.
Non- interesterified
Commercially available non-interesterified fat. 50g fat.
Non- interesterified fat
50 g fat provided as commercially available non-interesterified fat.
Control
Rapeseed oil. 50 g fat.
Rapeseed oil
50 g fat provided as commercially available rapeseed oil.
Saturated fat control
Butter. 50g fat
Butter
50g fat provided as commercially available spreadable butter
Interventions
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Interesterified fat
50 g fat provided as commercially available interesterified fat.
Non- interesterified fat
50 g fat provided as commercially available non-interesterified fat.
Rapeseed oil
50 g fat provided as commercially available rapeseed oil.
Butter
50g fat provided as commercially available spreadable butter
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
35 Years
75 Years
ALL
Yes
Sponsors
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King's College London
OTHER
Responsible Party
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Locations
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Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London
London, , United Kingdom
King's College London
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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HR-
Identifier Type: -
Identifier Source: org_study_id
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