Determine the gastric and neural correlates of bloating.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Gastric measures (MRI): Gastric volume, air and liquid gastric
compartments. 2) Subjective ratings of fullness and bloating. 3) Changes in
regional brain activity in brain regions associated with visceral perception
and processing, as assessed with perfusion fMRI.
Secondary outcome
Subjective feelings of appetite, thirst and nausea.
Background summary
Carbon dioxide contained in beverages can increase gastric volume, consequently
inducing a feeling of epigastric discomfort. Women are more subject to
dyspepsia, and gastric discomfort. In line with this bloating and fullness
sensations are often described by women as a limiting factor to beer
consumption, but surprisingly not to soft drink consumption. However, the
gastric and neural correlates of gastric bloating are ill-explored.
Study objective
Determine the gastric and neural correlates of bloating.
Study design
Randomized cross-over study with two treatments.
Intervention
Drinking 500 mL beer (1x training, 1x test) and a carbonated softdrink (1x) in
20 min.
Study burden and risks
The study will consist of an information meeting (~30 min), a training session
(~60 min; up to 30 min questionnaires, 20 min drinking test, 10-min dummy MRI
session) and two MRI sessions (~90 min each). During the MRI sessions
participants will repeatedly rate their gastric feelings, drink 500 mL of
either beer or a lemonade in 20 min and be scanned at baseline (t0) and 4 times
at 10 min intervals after drinking (t25, t35, t45, t55; total time in scanner:
50 min). The study is non-therapeutic to the participants. The risk associated
with participation is negligible.
Bomenweg 2
Wageningen 6703HD
NL
Bomenweg 2
Wageningen 6703HD
NL
Listed location countries
Age
Inclusion criteria
-Age: 18-40 years
-BMI: 18.5 - 25.0 kg/m2
-Healthy (as judged by the participant)
-On average consuming more than 1 unit of beer per month but less than 13 units per week.
-On average consuming more than 1 unit of soft drink per month but less than 13 units per week.
-Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician.
Exclusion criteria
-Drug use or medical conditions which may interfere with normal functioning of the digestive tract. -Drug use or medical conditions which may interfere with normal functioning of the circulatory system
-Drug use or medical conditions which may lead to unreliable fMRI results (including, but not limited to neurological conditions)
-Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening
-For women: having the intention to become pregnant, pregnancy during the last 6 months or lactating
- Smoking on average more than one cigarette/cigar a day
-Having a contra-indication to MRI scanning including, but not limited to, metal in the body and claustrofobia
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 | NL54050.081.15 |