The primary objective of this study is to investigate the effect of - short vs. long - oro-sensory exposure combined with a gastric load - low vs. high in energy -, on gastric emptying rate. As secondary outcome we want to investigate the effect of…
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 outcomes is: differences in gastric emptying rates.
Gastric emptying will be measured with a non-invasive breath test. Subjects
will come to the study centre and will receive the gastric load which is
labelled with a stable isotope: i.e. 13C. Breath samples will be collected at
ten different moments: 2 before the treatment and 8 times after the treatment.
In the breath samples the concentration of 13C (as part of 13CO2) will be
determined as a measure for gastric emptying. The collected breath samples will
be analysed for 13-C isotopic enrichment of the expired CO2 using Isotope Ratio
Mass Spectrometry. The differences between the treatments in recovery of the
isotope will be the outcome measures for gastric emptying.
Secondary outcome
The secondary outcome is:
Subjective feelings of satiety: To measure subjective feelings of satiety,
subjects will be asked multiple times to rate their feelings of satiety on a
questionnaire. This *Appetite questionnaire* will consist of seven dimensions,
i.e. hunger, fullness, prospective consumption, desire to eat, desire to eat
something sweet, desire to eat something savoury, and thirst. The rating will
be done by means of a Visual Analogue Scale (VAS), where subjects have to mark
a spot on a 100 mm horizontal line. This will be done at nine different moments
during each test session. Lines will be anchored by *not at all ** on the left
side and *extremely ** on the right side.
Background summary
One of the major issues in the current food-rich environment is that many
popular foods promote a positive energy balance, because of their low satiating
efficiency per calorie. One of the reasons for this may be the quick passage
through the mouth. In our last two studies (ABR: NL30728.081.09 and
NL35319.081.11), subjects simultaneously received oral and gastric stimulation,
which were manipulated independently of each other. In the last study
(NL35319.081.11) the volume of the gastric load was kept the same, but the
energy content was varied. We found that appetite feelings were both affected
by long oral exposure duration and high energy density of the gastric load.
However, subsequent energy intake was mainly affected by energy density of the
gastric load. We expect that the rate of gastric emptying might clarify these
differences in outcome between appetite ratings and energy intake. Therefore we
want to investigate the gastric emptying rate.
Study objective
The primary objective of this study is to investigate the effect of - short vs.
long - oro-sensory exposure combined with a gastric load - low vs. high in
energy -, on gastric emptying rate.
As secondary outcome we want to investigate the effect of - short vs. long -
oro-sensory exposure combined with a gastric load - low vs. high in energy -,
on subjective feelings of satiety.
Study design
This is a randomized, cross over, single centre, trial with 5 treatments and a
wash out period of at least 5 days in between test sessions. Subjects will have
a naso-gastric tube inserted in all 5 treatments.
Intervention
Treatments vary in oral exposure duration (0, 1 or 8 min) and in energy content
of the gastric load (0, 100 or 700 kcal) in 500 ml. There are 5 different
treatments:
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: control treatment: no oral exposure with 0 kcal/500 ml gastric load,
Study burden and risks
The study is non-therapeutic to the participant. In healthy subjects tube
insertion by an experienced nurse, is in general not a risky procedure.
Subjects enrolled in the study have to visit the research centre 7 times: once
for a screening, once for a training session and 5 times for the intervention.
An appropriate wash-out period of at 5 days, and a training session where
subjects undergo all required procedures before further inclusion, will reduce
the risks and dropout rate as much as possible. In our previous study
approximately 9% of the subjects (4 out the 46) stopped/were withdrawn after
the training session because the tube insertion was too great a burden for them
(no persistent complaints). The subjects who continued participation did not
experience (medical) problems related to the tube insertion and did not
withdraw because of the tube insertion. The other procedures and measurements
in this study are not invasive (questionnaires, breath samples).
Bomenweg 2
Wageningen 6703HD
NL
Bomenweg 2
Wageningen 6703HD
NL
Listed location countries
Age
Inclusion criteria
Gender: male
Age: 18 - 40 y
BMI: 18.5 - 25.0 kg/m2
Healthy: as judged by the participant
Exclusion criteria
• Smoking or drug abuse
• Gastro-intestinal diseases
• Diabetes, thyroid diseases or any other endocrine disorders
• Lack of appetite for any reason
• Hypersensitivity or food allergy for products used in this study
• Currently participating in another clinical trial or planning to start participation during this study.
• Taking any medication, except for light pain relieving medications which are available over the counter (acetylsalicylic acid or paracetamol).
• Problems with the respiratory tract, such as hyperventilation, asthma or bronchitis, which can cause problems when the naso-gastric tube is inserted.
• 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 | NL40863.081.12 |