To investigate whether there is a difference in gastric volume over time after ingestion of cow milk between lactose tolerant, habitual milk consumers reporting no GI symptoms and non-habitual milk consumers reporting GI symptoms after milk…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fysiologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric emptying half-time based on gastric content (volume in mL) over time.
Secondary outcome
Subjective GI symptoms, wellbeing, thirst and appetite.
Background summary
MRI allows to follow digestion of food products in real-time and to visualize
stomach contents in 3D in time providing information to determine gastric
emptying rates. Some people report to experience abdominal discomfort when
digesting cow milk without being lactose intolerant or allergic to cow milk
proteins. Inter-person variability in digestion of milk proteins in the stomach
en related differences in gastric emptying rate and intestinal digestion might
be the origin of those complaints.
Study objective
To investigate whether there is a difference in gastric volume over time after
ingestion of cow milk between lactose tolerant, habitual milk consumers
reporting no GI symptoms and non-habitual milk consumers reporting GI symptoms
after milk consumption.
Study design
Two groups will be compared: habitual milk drinkers without GI symptoms, who
consume at least 700 mL cow milk a week, and non-habitual milk drinkers with GI
symptoms, who consume a maximum of 200 mL cow milk a week.
Intervention
Ingestion of 250 mL cow milk.
Study burden and risks
Each research subject will partake in a screening session consisting of a 4-h
lactose breath test, and a MRI session of approximately 1.5 h where the
research subject will consume 250 mL cow*s milk. The cow*s milk will be UHT
processed and is, hence, considered eminently safe. Before and after
consumption MRI scans are made to measure gastric content. These measurements
are non-invasive and carry minimal risk. The burden of the screening session
and measurement sessions is anticipated to most likely be related to possible
mild abdominal discomfort and to mild fatigue and/or boredom. The latter will
be counteracted by allowing the research subjects to read (during the
screening) or to listen to the radio during the session (during screening and
measurement sessions). The study is non-therapeutic to the research subjects.
Stippeneng 4
Wageningen 6708
NL
Stippeneng 4
Wageningen 6708
NL
Listed location countries
Age
Inclusion criteria
Drinking cow milk (maximum of 200ml/week for those who declare to not drink habitually and a minimum of 700ml/week for those who declare to drink cow milk habitually)
Reporting/not reporting GI discomfort after cow milk consumption (depending on study group)
Female
BMI: 18.5 - 30 kg/m2
Age: 18 - 60 years
Healthy (self-reported)
Need to be willing to be informed about incidental findings of pathology
Exclusion criteria
Having a history of medical or surgical events related to the GI tract that may give rise to GI complaints
Medical drug use that influences the GI tract*s normal function, e.g. the motility, pH etc: among others use of proton pump inhibitors, antacids, anti-depressants etc.
Medical drug use that influence the GI tract*s microbiota: antibiotic use within 1 months prior to the pre-study screenings day
Mental status that is incompatible with the proper conduct of the study
Daily use of probiotics
Weekly use of laxatives
Lactose intolerance (medically diagnosed or tested with a lactose breath test in screening visit) and cow milk allergy
Reported unexplained weight loss or weight gain of > 5 kg in the month prior to screening
Reported slimming or medically prescribed diet
Reported vegan or macrobiotic life-style
Alcohol consumption of more than 14 glasses/week
Smoking more than 4 cigarettes a day
Not willing to give stool sample during the study
Being pregnant, having the intention to get pregnant, lactating or being under postmenopausal hormonal treatment
Not having a general practitioner
Having a contra-indication to MRI scanning
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66536.081.18 |
| OMON | NL-OMON27110 |