Status:
COMPLETED
Gastric Layering and Monitoring II
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
FrieslandCampina
Conditions:
Infant Formula
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
Rationale: Results from a previous study suggest that gastric layer formation, which is caused by emulsion instability as a result of gastric acidification/digestion, is different between breastmilk a...
Eligibility Criteria
Inclusion
- Male
- Apparently healthy (self-reported)
- Willing to be informed about incidental findings of pathology
- Willing to comply with the study procedures
Exclusion
- Allergy or intolerance for cow milk, lactose, soy and/or fish (self-reported)
- Gastric disorders or regular gastric complaints, for example heart burn
- Use of medication which alters the normal functioning of the stomach, such as: Medical drug use that influences the GI tract's normal function, e.g. motility, pH etc.: among others use of protein pump inhibitors, antacids, anti-depressants etc. (judged by study doctor)
- Medical drug use that influences the GI tract's microbiota: antibiotic use within one month prior to the pre-study screening day (judged by study doctor)
- Smoking (\>2 cigarettes a week)
- Drinking more than 14 glasses of alcohol a week
- Having given a blood donation in the past two months
- Hb value below 8.4 mmol/L (as measured with finger-prick method at screening)
- Having a contra-indication to MRI scanning, including, but not limited to:
- Pacemakers and defibrillators
- Intraorbital or intraocular metallic fragments
- Ferromagnetic implants
- Claustrophobia
- Participating in other research during the study period
- Being an employee or student of the division of human nutrition and health
- Not having a general practitioner
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05224947
Start Date
January 28 2022
End Date
April 22 2022
Last Update
April 1 2024
Active Locations (1)
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1
Wageningen University & Research
Wageningen, Gelderland, Netherlands, 6708WE