An interventional study of Interesterified fat and Non- interesterified fat in Healthy Adults, sponsored by King's College London. Completed at 2 sites in United Kingdom. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by King's College London · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Commercially available interesterifed fat spread. 50g fat.
Dietary Supplement: Interesterified fat
Commercially available non-interesterified fat. 50g fat.
Dietary Supplement: Non- interesterified fat
Rapeseed oil. 50 g fat.
Dietary Supplement: Rapeseed oil
Butter. 50g fat
Dietary Supplement: Butter
50 g fat provided as commercially available interesterified fat.
50 g fat provided as commercially available non-interesterified fat.
50 g fat provided as commercially available rapeseed oil.
50g fat provided as commercially available spreadable butter
Endothelial function
Flow mediated dilatation
Time frame: Up to 8 hours
Postprandial lipaemic response
Area under plasma TAG concentration/ time curve
Time frame: Up to 8 hours
Postprandial lipaemic response
Postprandial plamsa total fatty acid composition and non esterifed fatty acid
Time frame: Up to 8 hours
Metabolomic for assessment of atherogenic potential (lipoprotein) analysis
Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR
Time frame: Up to 8 hours
Glycaemic response
Plasma glucose concentration
Time frame: Up to 8 hours
Insulinaemic response
Plasma insulin concnetration
Time frame: Up to 8 hours
Nitric oxide bioavailability
Plasma nitric oxide species and NADPH oxidase activity
Time frame: Up to 8 hours
Oxidative stress
Plasma 8-isoprostane F2a
Time frame: Up to 8 hours
Inflammatory response
Plasma IL-6
Time frame: Up to 8 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King's College London