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

October 22, 2020 updated by: King's College London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9NH
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under plasma TAG concentration/ time curve
Time Frame: Up to 8 hours
Postprandial area under plasma TAG concentration/ time curve
Up to 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial lipaemic response
Time Frame: Up to 8 hours
Postprandial plamsa total fatty acid composition and non esterifed fatty acid
Up to 8 hours
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
Up to 6 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isotope lablelled parameters
Time Frame: Up to 8 hours
In sub-group, n=12, postprandial 13C TAG concentration and breath CO2 13C
Up to 8 hours
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
Up to 8 hours
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
Up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2017

Primary Completion (ACTUAL)

May 15, 2018

Study Completion (ACTUAL)

May 27, 2018

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (ACTUAL)

June 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HR-16/17-4397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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