Healthy Men Clinical Trial
Official title:
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used in commercial spreads versus the corresponding un-interesterified blend.
Aim: The current study aims to investigate the acute effects of commercially relevant
interesterified 'hardstock' versus the corresponding un-interesterified blend on
postprandial lipaemia, glycaemia, insulinaemia and gut hormone responses. Due to the
previously observed differences in gut hormones following interesterified palm oil and
un-interesterified palm oil by our group, we will also explore acute effects of these fats
on satiety and rates of gastric emptying.
Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a
fat with a higher proportion of palmitic acid in the middle position of the TAG (but the
same fatty acid composition), will alter postprandial lipid and glucose metabolism. It is
also hypothesised that differences in rates of absorption between the test fats will
influence gut hormone responses and feelings of satiety.
Subjects: Participants will include 10 healthy male volunteers. In order to determine the
'typical' response to the test fats, subjects must not be affected by metabolic syndrome in
any way (obesity, dyslipidemia, insulin resistance or hypertension), they must be
non-smokers (since smoking influences postprandial lipaemia), and be aged between the ages
of 18 and 45 years (since above this age metabolic changes may take place that may affect
the way that the body digests and metabolises lipids). Male volunteers have been selected as
they elicit a higher postprandial lipaemic response to a given fat load and therefore are
more sensitive to dietary manipulation.
Power calculation: A sample size of 10 has 80% power to detect a difference between means of
112.74 units in area under the curve in plasma TAG with a significance level (alpha) of 0.05
(two-tailed).
Expected value:
The study will provide novel information on the acute effects of commercially relevant
spreads on postprandial lipaemia and satiety. It will also explore possible mechanisms for
the predicted reduced lipaemia following the interesterified fat from measurements of
gastric emptying.
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