Effects of dietary fat structure on short term changes in blood lipids and insulin sensitivity

ISRCTN	ISRCTN20774126
DOI	https://doi.org/10.1186/ISRCTN20774126
Protocol serial number	N/A
Sponsor	King's College London (UK)
Funder	Malaysian Palm Oil Board (MPOB) (Malaysia)

Submission date: 26/02/2009
Registration date: 13/03/2009
Last edited: 07/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tom Sanders
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised cross-over design trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	IPART
Study objectives	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(s)	West Kent Research Ethics Committee gave approval on the 14th January 2009 (ref: 08/H1101/122)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	48
Key inclusion criteria	Healthy males and females, aged 18 - 45 years.
Key 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
Date of first enrolment	20/02/2009
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

United Kingdom
England
Netherlands

Study participating centre

Nutritional Sciences Division

London
SE1 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes