The effect of repetitive intake of lipids in alginate gel on food intake and satiety

Direct infusion of lipids into different parts of the human small intestine has
demonstrated to decrease food intake and subjective appetite feelings, to
increase production of the satiety hormones GLP-1, PYY, and CCK, and diminishes
gastrointestinal (GI) motility. Amongst oils with different degree of fatty
acid saturation, safflower oil (high in linoleic acid, C18:2) was found the
strongest inducer of the ileal brake. When ingested orally, however, the major
part of dietary lipids will be digested and absorbed in the proximal small
intestine and are not likely to induce the ileal brake mechanism. Incorporating
small lipid droplets into millimeter-sized calcium (Ca)-alginate gel particles
has shown promising results for ileal brake activation. Oral intake of these
lipid containing gels have proven to reduce food intake in humans without
inducing gastrointestinal symptoms. Contrastingly, to date little is known
about repetitive activation of mechanisms of satiety and the effect on food
intake. It is not known whether repetitive ileal brake activation provides a
stronger brake or whether this will lead to a blunted response and adaptation.
Therefore, in the present study we will investigate the effect of repetitive
intake of safflower oil droplets in Ca-alginate gels in yogurt over four days
on ad libitum food intake, satiety feelings and energy intake compensation.

Primary Objective: To investigate the effect of repetitive intake of lipids in
alginate gel over 4 days on ad libitum food intake in overweight subjects
Secondary Objective(s):
- To investigate the effect of repetitive intake of lipids in alginate gel over
4 days on energy intake compensation, satiety feelings and GI symptoms in
overweight subjects
- To investigate the acute effect of intake of lipids in alginate gel over 1
day on ad libitum food intake, energy intake compensation, satiety feelings and
GI symptoms in overweight subjects
- To compare the effect between the intake of lipids in alginate gel on the
first day and, after a 4 days treatment period, on the fourth day on ad libitum
food intake, energy intake compensation, satiety feelings and GI symptoms in
overweight subjects
- To investigate the effect of intake of lipids in alginate gel on food intake
in normal living setting

Single-blind, randomized, controlled trial with two treatments in a cross-over
design.

Each subject will receive two treatments in two research periods separated with
a minimum of one-week wash-out, and a maximum of 6 weeks in between research
periods. Each subject will consume the test product during four consecutive
days and participate in a test day on the first and last day of each research
period.

The subjects (in total 44) will have to visit the Centre for Healthy Eating and
Food Innovation (HEFI) at Maastricht University Campus Venlo (Sint Jansweg 20,
Villa Flora building, 5928RC, Venlo), on five occasions: once to sign the
informed consent form, fulfil the screening and get a verbal explanation (about
30-60 minutes) and four times to attend the test days (about 9 hours per test
day). The test days will be non-invasive: consumption of a breakfast, yogurt
snack, lunch, smoothie snack, and dinner; 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 VAS (0 to 100 mm), with the most negative or lowest intensity
feelings at the low end and the opposing terms at the high end. Finally, the
subjects will be asked to complete a food diary on six occasions corresponding
to the 2 days before starting each research period, and the 4 days where the
subjects will consume the test products in a normal living setting in each
research period.