To study gastric emptying of breastmilk and infant formula and to see whether gastric emulsion stability differs between breastmilk and infant formula.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fysiologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric content in mL over time and half gastric emptying time (t50)
mL of the individual layers within the stomach and the time when they are
observed.
Secondary outcome
The participants will be asked to rate their sense of fullness, bloating and
nausea from 0 to a 100.
Background summary
In some cases, breastfeeding is replaced with infant formula. Infant formula
should strive to mimic breastmilk as closely as possible. Gastric dynamics
after ingestion are unknown for both infant formula and breastmilk, as well as
their relative differences. Based on literature on gastric emptying and the
effect of homogenization, our hypothesis is that breastmilk behaves like an
unstable emulsion, while infant formula behaves like a stable emulsion.
Study objective
To study gastric emptying of breastmilk and infant formula and to see whether
gastric emulsion stability differs between breastmilk and infant formula.
Study design
Randomized cross-over design
Intervention
Each participant will drink 200 mL of her own breastmilk or, in another
session, commercial infant formula. Gastric content will be monitored using
magnetic resonance imaging (MRI). MRI scans will be done at baseline and at
time points t = 0, 10, 20, 30, 40, 50, 60 minutes after ingestion. Participants
are asked to come in fasted. The participants will be asked to rate their sense
of fullness, bloating and nausea from 0 to a 100.
Study burden and risks
Each participant will partake in 2 sessions of approximately 1.5 hours each.
The breastmilk (being their own) and infant formula are considered eminently
safe. After and before consumption MRI scans are made to measure gastric
content. These measurements are non-invasive and carry minimal risk. The burden
of the sessions is anticipated to most likely be related to mild fatigue and/or
boredom, which will be counteracted by allowing the participants to listen to
the radio during the session. Next to this, the participants have to lay still
at sveral time points and the MRI apparatus produces quite some noise. The
study is non-therapeutic to the participants.
Stippeneng 4 2
Wageningen 6708 WE
NL
Stippeneng 4 2
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
Female
Lactating
Given birth at least 4 weeks ago
Given birth to a single child, no twins
Being healthy (self-reported)
Non-smoking
Having given written informed consent
Need to be willing to receive information about incidental findings of pathology
Exclusion criteria
Lactating for more than 1 year
Bovine milk allergy or intolerance (self-reported)
Lactose intolerance (self-reported)
Gastric disorders or regular gastric complaints, heart burn for example
Use of proton pump inhibitors or other medication which alters the normal functioning of the stomach
Smoking
Inability to comfortably produce an additional 225 mL of milk
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 | NL64884.081.18 |