Condition category
Circulatory System
Date applied
26/02/2009
Date assigned
13/03/2009
Last edited
07/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tom Sanders

ORCID ID

Contact details

Nutritional Sciences Division
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The acute effects of triacylglycerol structure of palmitic acid rich fats on postprandial changes in lipid and glucose metabolism: a randomised cross-over trial

Acronym

IPART

Study hypothesis

Changing the triacylglycerol structure of palm oil by interesterification, to produce a fat with a high proportion of palmitic acid in the sn-2 position, will alter postprandial lipid and glucose metabolism. Postprandial responses to plant (interesterified palm oil) and animal (lard) fats with a high proportion of palmitic acid in the sn-2 position will be similar.

Ethics approval

West Kent Research Ethics Committee gave approval on the 14th January 2009 (ref: 08/H1101/122)

Study design

Randomised cross-over design trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diet and cardiovascular disease

Intervention

In a single test meal consisting of a muffin and a milkshake, three test fats (50 g) are compared versus a control fat (high oleic sunflower oil; 50 g). These are; native palm olein , chemically interesterified palm olein and lard.
1. Palm olein represents a palmitic acid-rich fat with palmitic acid almost exclusively (~90%) in the sn-1 and -3 positions
2. Chemically interesterified palm olein represents a palmitic acid-rich fat with a high proportion of palmitic acid in the sn-2 position (~33%)
3. Lard represents an animal fat with a high proportion of palmitic acid in the sn-2 position (~58%)
4. High oleic sunflower oil will be used as a reference oil for the control test meal

Contact details for joint Principal Investigator:
Professor Ronald P. Mensink, PhD
Department of Human Biology
School for Nutrition, Toxicology and Metabolism
Maastricht University
PO Box 616
6200 MD Maastricht
The Netherlands

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Postprandial changes in plasma glucose (measured at: 0, 15, 30, 60, 90, 120, 150, 180, 240, 300, 360, 420 and 480 minutes) and plasma triacylglycerol concentrations (measured at 0, 60, 120, 180, 240, 300, 360, 420 and 480 minutes). Both will be measured using enzymatic assays.

Secondary outcome measures

1. Apolipoprotein B48 concentrations, measured at 0, 180, 240, 300 and 480 minutes
2. The positional distribution of chylomicron lipids in the sn-2 position, measured at 180, 240 and 300 minutes
3. Non-esterified fatty acids, measured at 0, 60, 120, 180, 240, 300, 360, 420 and 480 minutes
4. Plasma fatty acids, measured at 0, 60, 120, 180, 240, 300, 360, 420 and 480 minutes
5. Total cholesterol, measured at 0, 60, 120, 180, 240, 300, 360, 420 and 480 minutes
6. Insulin, measured at 0, 15, 30, 60, 90, 120, 150, 180, 240, 300, 360, 420 and 480 minutes
7. C-peptide, measured at 0, 15, 30, 60, 90, 120, 150, 180, 240, 300, 360, 420 and 480 minutes
8. Gut hormones (including the incretin, glucose-dependent insulinotropic polypeptide, peptide YY and cholecystokinin), measured at 0, 15, 30, 60, 90, 120, 150, 180, 240, 300, 360, 420 and 480 minutes
9. Cytokines (interleukin-6, tumour necrosis factor alpha, E-selectin), measured at 0, 180, 240, 300 and 480 minutes
10. Factor VII activated concentrations, measured at 0, 180 and 360 minutes

Overall trial start date

20/02/2009

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy males and females, aged 18 - 45 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48 participants

Participant exclusion criteria

1. A reported history of heart disease, diabetes, cancer, kidney, liver or bowel disease (healthy volunteers are required)
2. Current cigarette smoker
3. History of substance abuse or alcoholism (previous weekly alcohol intake greater than 60 units/men or 50 units/women)
4. Current self-reported weekly alcohol intake exceeding 28 units
5. Unwilling to follow the protocol and/or give informed consent
6. Weight change of greater than 3 kg in preceding 2 months
7. Body mass index (BMI) less than 20 and greater than 35 kg/m^2
8. Blood pressure greater than 160/90 mmHg
9. Fasting blood cholesterol greater than 7.8 mmol/l, fasting plasma triacylglycerol concentrations greater than 3 mmol/l, or fasting plasma glucose greater than 7 mmol/L
10. Presence of gastrointestinal disorder or use of a drug, which is likely to alter gastrointestinal motility or nutrient absorption
11. Greater than or equal to 20% 10-year risk of cardiovascular disease (CVD) as calculated using the risk calculator
12. Vegetarian dietary practices
13. Pregnant women

Recruitment start date

20/02/2009

Recruitment end date

01/10/2009

Locations

Countries of recruitment

Netherlands, United Kingdom

Trial participating centre

Nutritional Sciences Division
London
SE1 9NH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Nutritional Sciences Division
Franklin Wilkins Building
150 Stamford St
London
SE1 9NH
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

Malaysian Palm Oil Board (MPOB) (Malaysia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22030225

Publication citations

  1. Results

    Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP, Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism., Am. J. Clin. Nutr., 2011, 94, 6, 1433-1441, doi: 10.3945/ajcn.111.017459.

Additional files

Editorial Notes