The primary objective of this study is to determine the effect of the duration of oro-sensory exposure and/or energy content of the gastric load, on subsequent energy intake.The secondary objectives of the research project are to determine the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
overweight and obesity
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is ad libitum energy intake of an ad libitum test meal
served 30 minutes after start of the oral exposure/ intragastric infusion. To
measure energy intake, the amount of provided food will be determined, as well
as the leftovers. Chemical analyses will be performed to determine the exact
energy and macronutrient content of the lunch.
Secondary outcome
Secondary outcomes measures are
- subjective feelings of satiety that are measured via Visual Analogue Scale
ratings. Hunger, fullness, prospective consumption, desire to eat, desire to
eat something sweet, desire to eat something savoury, thirst, wellbeing and
nauseous feelings will be rated.
- gastric emptying rate will be measured with a non-invasive breath test. The
gastric load which the subjects receive for the gastric stimulation will be
labeled with a stable isotope: 13-C acetate. After some time part of the 13-C
acetate will be present in the breath of the subjects. During a test day, 7
breath samples will be collected of a subject. The rate of gastric emptying
will be determined by measuring the 13-C isotopic enrichmen in the collected
breath samples.
Gastric emptying rate of 1min/800ml treatment
The gastric emptying rate of the 1min/800ml treatment will be compared to the
control, to see whether it is significantly quicker. That might be the reason
that we did not found a significant effect of gastric filling volume on ad
libitum energy intake in our previous study.
Background summary
One of the major issues in the current food-rich environment is that many
popular foods promote a positive energy
balance, because the consumption of these foods leads to a relatively low
satiety feeling relative to their energy content.
One of the reasons for this may be their swift passage through the mouth, which
decreases sensory signalling. This
decreased sensory signalling may lead to diminished CPRs and lower sensory
satiety. Consumption of fast foods, like
caloric liquids and highly energy-dense foods may disrupt the learned
connection between sensory signals and their
physiological consequences and thereby CPRs.
In order to prevent a positive energy balance upon consumption of energy dense
food products, there is a need to know
how sensory and gastric signals and their interaction affect satiety. The
understanding of which food properties have an
impact on the oral and gastric contributions to satiety creates opportunities
to optimize food products in such a way that
satiety is maximized.
Study objective
The primary objective of this study is to determine the effect of the duration
of oro-sensory exposure and/or energy content of the gastric load, on
subsequent energy intake.
The secondary objectives of the research project are to determine the effect of
short/long oro-sensory exposure combined with a gastric load low/high in
energy, on:
• subjective feelings of satiety
• gastric emptying rate
Furthermore we want to reproduce the results of one treatment (1min/800ml) of
our previous study (ABR nr 30728), to investigate whether the gastric load is
quickly emptied.
Study design
This is a randomized, cross over, single center, trial with 6 treatments:
Control: no oral exposure and no gastric load.
A: 1min oral exposure with 100kcal/500ml gastric load,
B: 8 min oral exposure with 100kcal./500ml gastric load,
C: 1 min oral exposure with 700kcal/500ml gastric load,
D: 8min oral exposure with 700kcal/500ml gastric load,
E: 1min oral exposure with 100kcal/800ml gastric load,
Subjects will have a naso-gastric tube inserted in all 6 treatments.
Intervention
All subjects will receive all 6 treatments, which are described under 'study
design, in randomised order. Oral stimulation is done with modified sham
feeding (MSF) with cake, and gastric stimulation is done with a mixture of cake
and water.
30 minutes after the start of the treatment, subjects will receive a lunch
meal, and are told to eat until they are comfortably full. Ad libitum food
intake during this lunch is the primary outcome of the study
Subjects will receive one treatment per test day, and between the test days a
minimum of 5 testfree days will be scheduled.
Study burden and risks
Subjects will have 1 visit at the university and 7 visits at the hospital,
that will last for 14.5 hours all together.
The stable isotope 13-C acetate is a natural stable isotope, it makes up about
1% of all natural carbon on earth and it is present in for example corn.
Naso-gastric intubation by an experienced nurse is usually a procedure with a
low risk. Especially in healthy subjects this will not cause problems in most
of the cases. We do not expect that repeated intubation - with a wash-out
period of at least 5 days - will give a higher risk than a single intubation.
In our previous study (ABR nr 30728) no complications occurred, nor did any of
the subjects reported enduring soreness/irritation of the nose or throat.
More insight in the sensory and gastric signals and their interaction in
satiety will be present after conducting the study.
The understanding of which food properties have an impact on the oral and
gastric contributions to satiety creates
opportunities to optimize food products in such a way that satiety is
maximized.
Avenue Nestle 55
CH-1800 Vervey
CH
Avenue Nestle 55
CH-1800 Vervey
CH
Listed location countries
Age
Inclusion criteria
Male, healthy (based on subjects own judgement), aged between 18 and 40 years, BMI between 18.5 and 25 kg/m2, stable body weight (no changes larger than 5kg over the past 2 months)
Exclusion criteria
• Smoking or drug use
• Taking any medication, except for light pain relieving medications which are available over the counter (aspirin or paracetamol).
• Gastro-intestinal diseases
• Diabetes, thyroid diseases or any other endocrine disorders
• Problems with the respiratory tract, such as hyperventilation, asthma or bronchitis, which can cause problems when the naso-gastric tube is inserted.
• Lack of appetite for any reason
• Restraint eating DEBQ score >= 2.26 (above average)
• Hypersensitivity or food allergy for products used in this study
• Currently participating or having participated in a clinical trial during the last 3 months prior to the beginning of this study.
• Working at, or doing an MSc. thesis at the Division of Human Nutrition
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35319.081.11 |