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

Sponsor
King's College London (Other)
Overall Status
Completed
CT.gov ID
NCT03191513
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
11.5
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Interesterified blend of palm kernal and plam stearin
  • Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin
  • Dietary Supplement: Rapeseed oil
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Actual Study Start Date :
Jun 12, 2017
Actual Primary Completion Date :
May 15, 2018
Actual Study Completion Date :
May 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interesterified

Interesterified blend of palm kernal and plam stearin. 50g fat.

Dietary Supplement: Interesterified blend of palm kernal and plam stearin
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

    		•
    Active Comparator: Un-interesterified

    Un-interesterified blend of palm kernal and plam stearin. 50g fat.

    Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin
    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

    		•
    Active Comparator: Control

    Rapeseed oil. 50g fat.

    Dietary Supplement: Rapeseed 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)
    Other Names:
  • Control fat

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under plasma TAG concentration/ time curve [Up to 8 hours]

      Postprandial area under plasma TAG concentration/ time curve

    Secondary Outcome Measures

    1. Postprandial lipaemic response [Up to 8 hours]

      Postprandial plamsa total fatty acid composition and non esterifed fatty acid

    2. Positional composition retention (chylomicron) [Up to 6 hours]

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

    Other Outcome Measures

    1. Isotope lablelled parameters [Up to 8 hours]

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

    2. Lipoprotein particle size and number [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 [Up to 8 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King's College London London United Kingdom SE1 9NH

    Sponsors and Collaborators

    • King's College London

    Investigators

    • Principal Investigator: Sarah EE Berry, PhD, King's College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College London
    ClinicalTrials.gov Identifier:
    NCT03191513
    Other Study ID Numbers:
    • HR-16/17-4397
    First Posted:
    Jun 19, 2017
    Last Update Posted:
    Oct 26, 2020
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by King's College London
    Interesterified
    Postprandial
    Lipid

    Study Results

    No Results Posted as of Oct 26, 2020