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Completed

NCT Number: NCT03191513

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

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.

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Key information

Conditions

Healthy Adults Postmenopausal Women

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE1 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interesterified blend of palm kernal and plam stearin

Dietary Supplement

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)

Other names: Interesterified blend

Un-interesterified blend of palm kernal and plam stearin

Dietary Supplement

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)

Other names: Un-interesterified blend

Rapeseed oil

Dietary Supplement

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)

Other names: Control fat

Primary outcomes

  1. Area under plasma TAG concentration/ time curve

    Time frame: Up to 8 hours

    Postprandial area under plasma TAG concentration/ time curve

Secondary outcomes

  1. Postprandial lipaemic response

    Time frame: Up to 8 hours

    Postprandial plamsa total fatty acid composition and non esterifed fatty acid

  2. Positional composition retention (chylomicron)

    Time frame: Up to 6 hours

    Postprandial chylomicron TAG concentration and composition, TAG sn-2 fatty acid composition, total protein, apoB100 and apoB48

Other outcomes

  1. Isotope lablelled parameters

    Time frame: Up to 8 hours

    In sub-group, n=12, postprandial 13C TAG concentration and breath CO2 13C

  2. Lipoprotein particle size and number

    Time frame: Up to 8 hours

    Lipoprotein size (LDL, VLDL and HDL) and composition (total and small LDL, large VLDL and total and large HDL) measured by NMR

  3. 2 and 3 MCPD and glycidyl esters

    Time frame: Up to 8 hours

    Postprandial plasma 2 and 3-monochloropropane-1,2-diol or 3-chloropropane-1,2-diol glycidyl esters

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Acronym: INTERMET

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2017
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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