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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03438084
Acronym
INTER-CARDIO
Enrollment
50
Registered
2018-02-19
Start date
2018-07-01
Completion date
2019-10-31
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Keywords

Interesterified, Postprandial, Lipid

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.

Interventions

DIETARY_SUPPLEMENTInteresterified fat

50 g fat provided as commercially available interesterified fat.

DIETARY_SUPPLEMENTNon- interesterified fat

50 g fat provided as commercially available non-interesterified fat.

DIETARY_SUPPLEMENTRapeseed oil

50 g fat provided as commercially available rapeseed oil.

DIETARY_SUPPLEMENTButter

50g fat provided as commercially available spreadable butter

Sponsors

King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial functionUp to 8 hoursFlow mediated dilatation
Postprandial lipaemic responseUp to 8 hoursArea under plasma TAG concentration/ time curve

Secondary

MeasureTime frameDescription
Glycaemic responseUp to 8 hoursPlasma glucose concentration
Insulinaemic responseUp to 8 hoursPlasma insulin concnetration
Postprandial lipaemic responseUp to 8 hoursPostprandial plamsa total fatty acid composition and non esterifed fatty acid
Oxidative stressUp to 8 hoursPlasma 8-isoprostane F2a
Inflammatory responseUp to 8 hoursPlasma IL-6
Nitric oxide bioavailabilityUp to 8 hoursPlasma nitric oxide species and NADPH oxidase activity
Metabolomic for assessment of atherogenic potential (lipoprotein) analysisUp to 8 hoursLipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026