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The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism

The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03191513
Acronym
INTERMET
Enrollment
24
Registered
2017-06-19
Start date
2017-06-12
Completion date
2018-05-27
Last updated
2020-10-26

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

Conditions

Healthy Adults, Postmenopausal Women

Keywords

Interesterified, Postprandial, Lipid

Brief summary

The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.

Detailed description

Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism. Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride (TAG; but the same fatty acid composition), will alter postprandial lipid metabolism. Subjects: Participants will include 24 healthy male and female (postmenopausal) volunteers aged between the ages of 45 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 10 males and 10 females is required to detect a (clinically relevant) difference (for males and females separately) between means of 0.3 mmol/L maximal difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out rate. Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.

Interventions

50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

DIETARY_SUPPLEMENTRapeseed oil

50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

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
45 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females aged 45-75 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
Area under plasma TAG concentration/ time curveUp to 8 hoursPostprandial area under plasma TAG concentration/ time curve

Secondary

MeasureTime frameDescription
Postprandial lipaemic responseUp to 8 hoursPostprandial plamsa total fatty acid composition and non esterifed fatty acid
Positional composition retention (chylomicron)Up to 6 hoursPostprandial chylomicron TAG concentration and composition, TAG sn-2 fatty acid composition, total protein, apoB100 and apoB48

Other

MeasureTime frameDescription
Isotope lablelled parametersUp to 8 hoursIn sub-group, n=12, postprandial 13C TAG concentration and breath CO2 13C
Lipoprotein particle size and numberUp to 8 hoursLipoprotein size (LDL, VLDL and HDL) and composition (total and small LDL, large VLDL and total and large HDL) measured by NMR
2 and 3 MCPD and glycidyl estersUp to 8 hoursPostprandial plasma 2 and 3-monochloropropane-1,2-diol or 3-chloropropane-1,2-diol glycidyl esters

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026