To investigate the effect of whey and casein ratio of IFT on intragastric behavior, gastric emptying and postprandial plasma metabolome
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fysiologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Top layer volume of the stomach contents
Secondary outcome
Total gastric content volume and blood parameters ((NMR-based) metabolomics
(focusing on the lipid metabolism), plasma free fatty acids, glucose &
insulin).
Background summary
It is important to develop follow-on and toddler formulae (IFT) that more
closely resembles human milk to provide an adequate alternative if mothers do
not breastfeed. Results from a previous study suggested that gastric layer
formation, which is caused by emulsion instability as a result of gastric
acidification/digestion, is different between breastmilk and infant, IFT. This
may be due to differences in protein composition, which in turn may contribute
to the observed differences in gastric emptying rate between breastmilk and
IFT. The hypothesis for the current study is that differences in whey and
casein ratio will affect gastric behavior and thereby gastric emptying rate and
the postprandial plasma metabolome.
Study objective
To investigate the effect of whey and casein ratio of IFT on intragastric
behavior, gastric emptying and postprandial plasma metabolome
Study design
Double-blind cross-over study with two treatments.
Intervention
After an overnight fast, participants will drink 600 mL of one of two IFTs
which differ in protein composition. Gastric content will be monitored using
Magnetic Resonance Imaging (MRI). MRI scans will be done at baseline and at
time points t = 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120
minutes after the start of ingestion and blood samples will be taken at
baseline and at t = 15, 30, 45, 60, 75, 90, 105 and 120 minutes for plasma
metabolomic analyses. In addition, verbal ratings of hunger, fullness, bloating
and nausea will be collected.
Study burden and risks
The risks associated with participation are low, as both phlebotomy and MRI are
eminently safe medical techniques. In addition, the IFTs are safe. Each
participant will participate in 2 sessions, which require 9 blood withdrawals
(in total 120 mL per visit) and multiple MRI scans over a period of
approximately 2 hours. These measurements are non-invasive and carry minimal
risk. The burden of the sessions is most likely related to mild discomfort as
they have to lie still in the MRI for two hours. This will be minimized by the
soft mattress on the bed of the MRI, leg rest and a pillow underneath the head.
The study is non-therapeutic to the participants.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
Male
Age 18 * 45 y
Healthy (self-reported)
Normal-weight (BMI 18.5 * 25kg/m2)
Willing to be informed about incidental findings of pathology
Willing to comply with the study procedures
Exclusion criteria
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.) or the GI tract's microbiota (e.g. antibiotics).
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)
Having contra-indication to MRI scanning (e.g. having a pacemaker,
defibrillator, intraorbital or intraocular metallic fragments, ferromagnetic
implants, or being claustrofobic)
Participating in other research during the study period
Not having a general practitioner or unwillingness to share unexpected findings
with the general practitioner
Being an employee or student of the division of human nutrition and health
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 | NL77717.091.21 |
| Other | Zal parallel worden geregistreerd in Dutch Trial Register |