Appetite Regulation Clinical Trial
Official title:
Functional MRI of Satiety, the Interaction Between Gastric and Oral Stimulation and Related Hormones in Healthy Men
The amount and kind of food which is ingested influences the regulation of meal size. Neural signals from the gastrointestinal tract travel via the vagus nerve to the brainstem and thalamus, which projects to the rest of the brain, in particular the hypothalamus, amygdala and primary sensory cortices. In neuroimaging studies in which the stomach was distended with a gastric balloon activation was observed in the right insula, left posterior amygdala, left posterior insula, left inferior frontal gyrus and anterior cingulate cortex. So far, no study has examined the effects of the ingestion or infusion of a food on the brain. In addition to neural signals, hormonal signals are important for meal termination. Hormones like insulin, ghrelin and cholecystokinin interact with gastric as well as sensory signals in the process of satiation, which ultimately leads to meal termination. The aim of this study is to investigate the interaction between food administration, hormone responses and brain responses. To this end an oral or intra-gastric load will be administered while measuring brain activity (functional magnetic resonance imaging) and hormone concentrations. Subjects will participate in one trainings session and in three functional magnetic resonance imaging (fMRI) sessions (35-min fMRI scan). A training session will take 40-minutes and consists of placing a naso-gastric tube and ingesting 500 ml of chocolate milk orally. The fMRI sessions will consist of three conditions: in condition one (A) 500ml of chocolate milk will be administrated orally. In condition two (B) and three (C) an intra-gastric load of 500 ml is administrated.
Study procedures
1. Screening: Before inclusion in the study, potential subjects will complete a screening
questionnaire Subjects will then be informed about their eligibility. Also the
procedure and risks will be explained. If they decide to participate, they will fill in
and sign the standard MRI-screening form and the informed consent form. Also a training
session date will be planed.
2. Training session: When subjects want to participate and match to the criteria a
training session will be planned. During this training session a naso-gastric tube will
be inserted by a qualified nurse (according to the "maagsonde-protocol" UMC Utrecht).
After insertion of the tube subjects rest to allow water used to assist insertion of
the tube to leave the stomach and to become comfortable with the tube. During this
insertion the nurse and the subject can see if a subject can handle the naso-gastric
tube and can or will participate in the study. Subjects will rate hunger, fullness,
thirst, desire to eat, prospective consumption, nauseous, and anxiety on a VAS scale.
To simulate the position in the MR scanner, subjects will be asked to lie down on a
doctors table. A towel will be placed under need there right side, in this way the
stomach will be more in the position when standing/sitting, this is to simulate normal
gastric filling. A tube will be placed between the teeth of the subject (like a straw)
after which an oral load of 500 ml will be ingested through the tube in the month. This
ingestion will be driven by a pomp (100ml/min), which simulates a sip systematically.
First 200 ml will be ingested, then there will be a pause of 30 seconds, second the
next 150 ml will be pumped, following again a 30 second rest period, then the last 150
ml will be ingested. The subjects know the rate and speed of the sips and can stop the
pomp on command when necessary. The subject will also hear a tone just before the sip
is ingested. Here a subject learns to drink with a naso-gastric tube placed and when
lying down. After ingestion the subjects will fill in the same questionnaire again. The
naso-gastric tube will be removed after the rating. This training session will take
about 40 minutes.
3. Assessments and procedures on the study days: All subjects will be asked to arrive in
the morning after an overnight fast of at least 10 hours. The evening before the scan
subjects will be ask to eat a standardized meal given by the researchers (AH kant &
klaar). An appetite questionnaire will be filled in (hunger, fullness, thirst, desire
to eat, quantity to eat, desire to eat something sweet or savory, nauseous, and
anxiety). An intravenous cannula will be placed by a qualified person. Next, the
naso-gastric tube will be placed (same procedure as training session). After the
subject has been placed in the scanner (as in the training session with a towel under
need there right side); one blood draw will be done for baseline measurements (e.g.
glucose, insulin, cholecystokinin and ghrelin for every time point). The appetite
questionnaire will be filled in again in the scanner. A reference and anatomic scan
will be done. Now the fmri session begins; after five minutes of baseline scanning,
food administration will start (t = 0). This consists of administration of the intra
gastric load through the naso-gastric tube (caloric or non-caloric) or of ingestion of
the caloric load through a tube (oral). Blood will be drawn at t = 2.5, t = 5, t = 10,
t = 15 and at t = 30 min. Before every blood sample subjects will give fullness and
nausea ratings. One of the researchers will stand next to the subject/scanner during
the whole experiment. If aspiration occurs a researcher will be there to help
immediately. The researchers also make sure a subject knows how to get out of the
scanner as quick as possible if aspiration occurs. At t = 30 min the subject will be
taken out the scanner and fill in the appetite questionnaire. The naso-gastric tube and
intravenous cannula will be removed. Subsequently subjects will be provided with an ad
libitum breakfast buffet at t = 45 min. Food weight and macro-nutrient intake will be
recorded. After breakfast the appetite questionnaire is filled in once more.
4. Blood sampling and storage: On the study day, a 10 ml blood sample will be drawn by
certified experienced medical personnel. Blood samples will be put on ice immediately
and then centrifuged at 1730 × g for 10 min at 4 ˚C. Blood material from the collection
tubes will be split into two portions and stored, one portion for the analyses and one
portion as a backup. Blood serum will be stored at -80 ˚C at the Rudolf Magnus
Institute until sample collection is complete. Only RMI laboratory personnel and the
investigators will have access to the samples. Blood samples will be coded as follows:
P01, P02, etc. The key to this code will only be known by the principal and medical
investigators and not by the personnel performing the blood analyses. Samples will be
kept for 10 years and then destroyed.
5. Naso-gastric tube: A qualified nurse will place the naso-gastric tube. The placement
will go according to the 'maagsonde -protocol' (UMC Utrecht). After insertion of the
tube subjects rest to allow water used to assist insertion of the tube to leave the
stomach and to become comfortable with the tube.
6. Withdrawal of individual subjects: Subjects can leave the study at any time for any
reason if they wish to do so without any consequences. The investigator can decide to
withdraw a subject from the study for urgent medical reasons. Each subject who does not
complete the study for any reason will have a post-study screening by the end of the
particular study day to ensure that the drop-out is not the result of a structural
problem. Data of subjects who withdrew prematurely will be used for statistical
analyses, as far as possible.
7. Replacement of individual subjects after withdrawal: In case subjects withdraw during
the study (fMRI sessions), they will not be replaced. If a subject decides not to
participate during the training session a new subject will be recruited.
8. Follow-up of subjects withdrawn from treatment: Subjects who withdraw from the study
will not be followed up, unless they withdraw because of an adverse event.
9. Post-study screening: Subjects will be asked how they experienced the study procedures.
This information, if the subject is willing to share it, will be used to evaluate (the
burden of) the study protocol.
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