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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22030225
Publication citations
-
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.