To investigate whethere there is a difference in gastric emptying (emptying half-time t50) after ingestion of cow milk between lactose tolerant, habitual milk consumers reporting no gastro-intestinal symptoms and non-habitual milk consumers…
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 (t50) derived from gastric content (volume in mL)
over time.
Secondary outcome
Subjective GI symptoms, thirst and appetite.
Background summary
Some people report gastro-intestinal discomfort after the ingestion of milk
without being lactose intolerant or being allergic to milk. It is hypothesised
that interpersonal differences such as proteolytic activity and related
different gastric emptying pattern are the underlying cause for the experienced
symptoms.
Study objective
To investigate whethere there is a difference in gastric emptying (emptying
half-time t50) after ingestion of cow milk between lactose tolerant, habitual
milk consumers reporting no gastro-intestinal symptoms and non-habitual milk
consumers reporting gastro-intestinal symptoms after cow milk consumption.
Study design
Two groups, habitual milk drinkers without gastro-intestinal symptoms, who
consume at least 700ml cow milk per week, and non-habitual milk drinkers with
gastro-intetstinal symptoms, who consume a maximum of 200ml cow milk per week.
Intervention
Ingestion of 250ml cow milk.
Study burden and risks
Each research subject will partake in one screening session of a 4 hours
lactose breath test, and in one MRI session of approximately 1.5 hours where
the research subject will consume 250ml 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 one
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 milk habitually and a minimum of 700ml/week for those who declare to drink milk habitually)
Do report/do not report GI discomfort after milk consumption (depending on study group)
Not lactose intolerant (tested with lactose breath test)
Female
BMI:18.5 * 30 kg/m2
Age: 18 - 60 years
Healthy (self-reported)
Having given informed consent
Need to be willing to be informed about incidential 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 microbiom: antibiotic use within 1 months prior to the pre-study screenings day
Daily consumption of probiotics
Weekly use of laxatives
Lactose intolerance (medically diagnosed) and cow milk allergy
Reported unexplained weight loss or weight gain of > 5 kg in the month
Reported slimming or medically prescribed diet, vegan or macrobiotic life-style
Alcohol consumption of more than 14 glasses/week
Smoking more than 4 cigarettes a day
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65385.081.18 |