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van CCT (UK)


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Gastric and neural correlates of bloating


- candidate number22932
- NTR NumberNTR5418
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2015
- Secondary IDsCCMO NL54050.081.15
- Public TitleGastric and neural correlates of bloating
- Scientific TitleGastric and neural correlates of bloating
- ACRONYMBLOB
- hypothesisBeer induces more bloating than carbonated soft drinks and this effect is more prominent in women compared to men as measured from theh stomach and in regional brain activation.
- Healt Condition(s) or Problem(s) studiedBloating, Dyspepsia
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2015
- planned closingdate1-jan-2016
- Target number of participants30
- InterventionsConsumption of 500 mL beer or carbonated soft drink.
- Primary outcome1) Gastric measures (MRI): Gastric volume, air and liquid gastric compartments.
2) Subjective ratings of fullness and bloating.
3) Changes in regional brain activity
- Secondary outcomeSubjective feelings of appetite, thirst and nausea; obtained on scan days just before and after participants are scanned.
- TimepointsTwo study days.
- Trial web siteNone.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jac Niessen
- CONTACT for SCIENTIFIC QUERIESDr. Paul A.M. Smeets
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Wageningen University, Heineken BV
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-okt-2015 - 4-nov-2015


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