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ISRCTN
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ISRCTN16669399
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ClinicalTrials.gov identifier
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Public title
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The chronic effects of triacylglycerol structure of palm oil on glucose homeostasis, insulin secretion and sensitivity and lipid metabolism
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Scientific title
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The chronic effects of triacylglycerol structure of palm oil in healthy adults on glucose homeostasis, insulin secretion and sensitivity and lipid metabolism: a single-blind, randomized crossover trial
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Acronym
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N/A
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Serial number at source
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7221 (NMRR research ID)
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Study hypothesis
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1. Changing the triacylglycerol (TAG) structure of palm olein by interesterification, toproduce a fat with a higher proportion of palmitic acid in the sn-2 position, will alter glucose homeostasis, beta-cell activity (insulin secretion), insulin sensitivity and fasting plasma lipids.
2. Palm olein will not differ from high monounsaturated fatty acids (MUFA) oils with regards to its effects on insulin sensitivity and release.
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Lay summary
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Lay summary under review
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Ethics approval
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National Institute of Health (NIH), 06 January 2011
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Study design
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Single-centre single-blind randomized crossover trial
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Countries of recruitment
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Malaysia
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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Healthy male and female participants, aged between 20 and 50 years
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Participants - exclusion criteria
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1. Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes 2. 2. Participants with metabolic syndrome as defined by the International Diabetes Federation (http://www.idf.org/webdata/docs/MetS_def_update2006.pdf)
3. Underweight [Body mass index (BMI) < 18.5 kg/m2] or obese (BMI ≥ 30 kg/m2)
4. Plasma cholesterol > 7.0 mmol /L
5. Plasma triacylglycerol > 3 mmol /L
6. Plasma glucose > 7 mmol /L
7. Current use of antihypertensive, lipid lowering, insulin / glucose modulating medication
8. Alcohol intake exceeding a moderate intake (> 21 units/week for males and > 14 units/week for females)
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Anticipated start date
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01/02/2011
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Anticipated end date
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28/07/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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54
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Interventions
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The dietary intervention will involve provision of 20% energy intake (approximately 45 g/d if based on a 2000 kcal basic diet) from the 3 test fats - palm olein (control), interesterified palm olein and high oleic sunflower oil (reference oil). Participants will first follow the intervention using the control test fat for 2 weeks, after which they will randomly be allocated to one of the 3 test diets for 6 weeks per intervention.
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Primary outcome measure(s)
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1. β-cell function (measured as the increments in C-peptide response to a mixed meal) will be measured at fasting, 10, 20, 30, 60, 90 and 120 minutes postprandially. These measurements will be taken at the baseline visit, 6, 12 and 18 week visits.
2. C-peptide will also be measured at fasting at the 3, 9 and 15 week visits. C-peptide will be measured using a solid-phase, two-site chemiluminescence immunoassay
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Secondary outcome measure(s)
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1. Insulin and glucose concentrations will be measured at fasting (in duplicate separated by a 5-minute interval), 10, 20, 30, 60, 90 and 120 minutes postprandially at the baseline visit, 6, 12 and 18 week visits.
2. Insulin and glucose concentrations will also be measured at fasting (in duplicate as described above) at the 3, 9 and 15 week visits. Insulin will be measured using a solid phase, two-site chemiluminescence immunoassay and glucose will be measured using an endpoint enzymatic reaction.
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Sources of funding
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Malaysian Palm Oil Board (MPOB) (Malaysia)
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Trial website
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Publications
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Contact name
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Prof
Tom
Sanders
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Address
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150 Stamford Street
Franklin Wilkins Building
King's College London
Waterloo
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City/town
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London
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 4273
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Fax
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+44 (0)20 7848 4171
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Email
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tom.sanders@kcl.ac.uk
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Sponsor
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King's College London (UK)
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Address
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c/o Professor Tom Sanders
150 Stamford Street
Franklin Wilkins Building
Waterloo
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City/town
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London
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 4273
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Fax
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+44 (0)20 7848 4171
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Email
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tom.sanders@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk/index.aspx
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Date applied
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30/08/2011
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Last edited
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19/09/2011
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Date ISRCTN assigned
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19/09/2011
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