The effect of orally applied encapsulated lipids in yoghurt on satiety and food intake: a randomized single-blind study with cross-over design

Sensing of lipid fractions in the small intestine can induce negative feedback
mechanisms from different parts of the intestine to the proximal
gastrointestinal (GI) tract including stomach, gallbladder and pancreas but
also to the central nervous system. This negative feedback process is able to
inhibit food digestion, appetite sensations and food intake, and is able to
increase feelings of satiety and satiation. The ileal brake is considered a
potent feedback mechanism not only during short-term intervention with ileal
lipid infusion, but also as powerful long-term weight management strategy with
orally ingested ileal lipid deliveryhen ingested orally. However, the major
part of dietary lipids will be digested and absorbed in the proximal small
intestine and is not likely to reach the distal ileum and induce the strong
ileal brake feed back mechanism. To prevent orally applied lipids to be
proximal digested and absorbed, we designed a food-grade encapsulation system
that releases free fatty acids from safflower oil in the more distal small
intestine. The current study will be an explorative study to proof the concept
of ileal brake activation: the encapsulated lipid will be added to and mixed
with yoghurt (A), and the subsequent satiety and food intake will be compared
to an equicaloric mixture of non-encapsulated nutrients (control, yoghurt B)
with the same amount of lipids, and the encapsulation components.

To explore the ability of encapsulation of orally applied lipids in a yoghurt
snack to modify ad libitum food intake and satiety, without GI symptoms.

Randomized, single-blind, placebo-controlled intervention study with cross-over
design.

Every subject receives two treatments on two different days with at least one
week in between, following a randomized cross-over design. On the test day, the
subjects will arrive in fasted state and receive a standardized breakfast
(small, low in fat, t=0 min). Once major part of the breakfast has been emptied
from the stomach (t=90 min), they receive a yoghurt (0.2 L) that contains
emulsified safflower oil (6 g) either encapsulated (yoghurt A) or
non-encapsulated (control, yoghurt B; same oil droplet size as intervention and
in presence of *empty* encapsulation matrix). Two hours after the intervention
yoghurt, once the lipid will be released to the distal small intestine, ad
libitum meal intake will be measured (t=210 min).

The subjects (in total 35) will have to visit Maastricht University on three
occasions: once to fulfil the screening and get an instruction (about half an
one hour) and two times to attend the test days (about four hours per test
day). The test days will be non-invasive: consumption of a breakfast, yoghurt
snack, and lunch; and in between filling questionnaires on satiety feelings
(satiety, fullness, hunger, desire to eat, desire to snack) and GI symptoms
(bloating, discomfort, pain, nausea). These attributes will be measured using
Visual Analogue Scales (VAS, 0 to 100 mm) scores, with the most negative or
lowest intensity feelings at the low end and the opposing terms at the high
end. The subject will be asked to indicate his feeling at that moment.
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