Effects of dietary fat structure on short term changes in blood lipids and insulin sensitivity
| ISRCTN | ISRCTN20774126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20774126 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Nutritional Sciences Division
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
Study information
| Study design | Randomised cross-over design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 20/02/2009 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 participants |
| 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
- England
- Netherlands
- United Kingdom
Study participating centre
Nutritional Sciences Division
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Nutritional Sciences Division
Franklin Wilkins Building
150 Stamford St
London
SE1 9NH
England
United Kingdom
| Website | http://www.kcl.ac.uk |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Malaysian Palm Oil Board (MPOB) (Malaysia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
