To explore the effect of additional protein in plant-based drinks. In addition, gastric protein coagulation will be examined for one of the plant-based drinks and compared to that of bovine milk.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fysiologie van voedselverwerking.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postprandial plasma amino acid profiles over time
Secondary outcome
Gastric protein coagulation (change from t=5 over time)
Gastric content volume (mL) (amount over time)
Time to peak amino acid concentration (min)
Postprandial glucose and insulin (change in concentration from baseline over
time)
Postprandial FGF21 (amount over time)
Appetite and wellbeing verbally rated on a scale from 0 to 100
MRI markers of digestion (MT, T2)
Background summary
There is a growing interest in plant-based alternatives for bovine milk.
However, these plant-based drinks are not a complete nutritional substitute for
bovine milk, especially when focusing on the protein content and quality of
these products. Knowledge on the effects of added protein to plant-based drinks
on postprandial amino acid profiles and gastric behavior compared to bovine
milk is lacking.
Study objective
To explore the effect of additional protein in plant-based drinks. In addition,
gastric protein coagulation will be examined for one of the plant-based drinks
and compared to that of bovine milk.
Study design
Single-blind randomized cross-over study with three treatments.
Intervention
After an overnight fast, participants will drink 750 mL of cow*s milk, a
plant-based milk low in protein or a plant-based milk high in protein. Gastric
content and coagulation will be monitored using Magnetic Resonance Imaging
(MRI) for the cow*s milk and plant-based milk high in protein. MRI scans will
be made at baseline and at time points t = 5, 15, 30, 45, 60, 75, 90, 105 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, 120, 150, 180, 210, 240 and
300 minutes for plasma metabolomic analyses. In addition, verbal ratings of
appetite and wellbeing 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 dietary interventions are
safe. Each participant will participate in 3 sessions, which require an
overnight fast, 14 blood withdrawals (in total 154 mL per visit) and for 2
sessions multiple MRI scans (during 2 hours), over a period of approximately
5.5 hours. These measurements are non-invasive and carry minimal risk. The
burden of the sessions is most likely related to mild discomfort as
participants must lie still in the MRI for 2 hours (after 2 hours there is no
more need to lay still and participants are allowed to move/sit). Discomfort in
the MRI will be minimized by the soft mattress on the bed of the MRI, leg rest
and a pillow underneath the head.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
Male
Age between 18 and 45 years
BMI between 18.5 and 25 kg/m2
Apparently healthy (self-reported)
Willing to be informed about incidental findings of pathology and consenting to
informing their general practitioner about this.
Exclusion criteria
Allergy or intolerance for cow milk, lactose and/or gluten (self-reported)
Gastric disorders or regular gastric complaints, for example heartburn Use of
medication which alters the normal functioning of the stomach, such as: o
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) o 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/week) Having a chronic illness that could affect food digestion and
nutrient absorption including but not limited to kidney disease, thyroid
disease and diabetes mellitus (self-reported) Alcohol consumption of more than
14 glasses/week Following a vegan diet Having a chronic illness that could
affect food digestion and nutrient absorption including but not limited to
kidney disease, thyroid disease and diabetes mellitus (self-reported). Having a
contra-indication to MRI scanning, including, but not limited to: o Pacemakers
and defibrillators o Intraorbital or intraocular metallic fragments o
Ferromagnetic implants o Claustrophobia Having given blood donation in the past
two months Hb value below 8.5 mmol/l Participating in other research during the
study period Not having a general practitioner
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | Het onderzoek zal voor aanvraag worden geregistreerd in Clinicaltrials.gov. |
| CCMO | NL83162.091.22 |