Clinical trial NCT03191513: The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Official title: The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Postmenopausal Women
Keywords: Interesterified
Postprandial
Lipid
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 24
Sex: ALL
Minimum age (years): 45
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 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.

Eligibility criteria: 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

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
* Premenopausal (for women)
* Alcohol intake exceeding a moderate intake (\> 28 units per week)
* Current cigarette smoker (or quit withint the last 6 months)
* ≥ 20% 10-year risk of CVD as calculated using a risk calculator

Primary outcomes:
measure: Area under plasma TAG concentration/ time curve
timeFrame: Up to 8 hours
Secondary outcomes:
measure: Postprandial lipaemic response
timeFrame: Up to 8 hours
measure: Positional composition retention (chylomicron)
timeFrame: Up to 6 hours
Other outcomes:
measure: Isotope lablelled parameters
timeFrame: Up to 8 hours
measure: Lipoprotein particle size and number
timeFrame: Up to 8 hours
measure: 2 and 3 MCPD and glycidyl esters
timeFrame: Up to 8 hours
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Sarah EE Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burnap SA, Sattler K, Pechlaner R, Duregotti E, Lu R, Theofilatos K, Takov K, Heusch G, Tsimikas S, Fernandez-Hernando C, Berry SE, Hall WL, Notdurfter M, Rungger G, Paulweber B, Willeit J, Kiechl S, Levkau B, Mayr M. PCSK9 Activity Is Potentiated Through HDL Binding. Circ Res. 2021 Nov 12;129(11):1039-1053. doi: 10.1161/CIRCRESAHA.121.319272. Epub 2021 Oct 4.