The objective of this study is to validate MRI as a functional measuring device for directly monitoring gastric emptying in vivo, while creating an overview of the influence of viscosity and nutrient density on gastric emptying times.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
normale fysiologie van het Maagdarmstelsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is stomach size/content as measured by MRI over a time
of 2 hours. The outcome of the study is the difference in these measured
parameters between the 4 treatments.
Secondary outcome
Participants will be asked to rate their feelings of appetite on a
questionnaire just before and after they are scanned. This questionnaire will
consist of four dimensions of appetite, i.e. hunger, fullness, desire to eat
and prospective consumption. Moreover, participants will rate their thirst, and
wellbeing i n this questionnaire. In addition, palatability and desire to
consume the stimuli will be rated in the scanner. Responses will be reported
on 100-mm visual analogue scales.
Exhaled air is measured for for isotopic enrichment using mass spectrometry, in
order to compare this with the MRI data.
Background summary
After ingesting food, the bolus ends up in the stomach. The stomach has many
functions, from secreting digestive fluids to kneading the contents and early
absorption of small amounts of specific nutrients. The time food resides in the
stomach is not only relevant for these processes, but also for the feeling of
*being full*. Though there are indirect ways to measure the gastric emptying
rate, better and more direct measuring techniques can yield better
understanding and more accurate scientific research. Magnetic Resonance Imaging
(MRI) offers the possibility to directly observe the process of gastric
emptying.
Study objective
The objective of this study is to validate MRI as a functional measuring device
for directly monitoring gastric emptying in vivo, while creating an overview of
the influence of viscosity and nutrient density on gastric emptying times.
Study design
The study has a randomized crossover design (within subject design) in which
participants ingest 500 ml liquid meals (or a 500 ml water control), which
differ in viscosity and nutrient content. The shakes are marked with a 13C
stable isotope, in order to measure gastric emptying using mass spectrometry on
exhaled air, this is the current clinical measure of gastric emptying.
Stimuli:
Shake B
Low viscosity - High nutrient
Shake D
High viscosity - High nutrient
Shake A
Low viscosity - Low nutrient
Shake C
High viscosity - Low nutrient
Control
Water
Overview of study for one participant:
Screening, scan session 1, scan session 2, scan session 3, scan session 4,
Scan session:
Arrival, sign MRI form, lie down in scanner: scan of empty stomach, drink
random shake, scan very 10 minutes of stomach for 2 hours including exhaling in
a sample bag, end session
Each participant will randomly be assigned an order of shakes. Also at a random
session out of the 4 the liquid shake will be preceded by the water control.
The sessions will be planned with at least one day apart.
Intervention
Stimuli:
Shake B
Low viscosity - High nutrient
Shake D
High viscosity - High nutrient
Shake A
Low viscosity - Low nutrient
Shake C
High viscosity - Low nutrient
Control
Water
Study burden and risks
The study has no direct benefits to the participants, with the possible
exception of getting a drinkable meal.
The study is non-therapeutic, The risk associated with the study is deemed
negligible.
Bomenweg 2
Wageningen 6703 HD
NL
Bomenweg 2
Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
Male
18-35
BMI: 18.5 - 25.0 kg/m2
Healthy as judged by the participant
Exclusion criteria
• Failing to meet one or more of the inclusion criteria
• Having difficulties with swallowing/eating
• Weight loss or weight gain of 5 kg or more during the last two months
• Having an endocrine or gastrointestinal disorder which may affect gastric emptying.
• Being allergic/intolerant for products under study (see form F1)
• Working at the Division of Human Nutrition (WUR)
• Current participation in other research from the Division of Human Nutrition (WUR)
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 | NL48059.081.14 |