To compare gastrointestinal digestion (gastric emptying and postprandial amino acids dynamics) between two dairy-based drinks containing casein and matched on macronutrient composition but differing in mineral composition.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
eiwitvertering bij gezonde mensen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Postprandial plasma amino-acid concentrations
2. Gastric emptying rate
Secondary outcome
1. Glucose and insulin
2. Coagulation and other product instabilities if visible
3. Fullness, bloating, nausea ratings obtained after each MRI measurement
Background summary
The degree of casein coagulation in the stomach can affect the dynamics of
gastric protein digestion, stomach emptying and subsequent intestinal digestion
and absorption of amino-acids. Previous studies (predominantly in vitro)
suggest that casein coagulation is affected by several factors including
processing-induced protein modifications, overall product composition
(including mineral composition) and variations in gastric acidification and
protease secretion. Particularly for the effect of product mineral composition
on casein coagulation in vivo studies are lacking.
Study objective
To compare gastrointestinal digestion (gastric emptying and postprandial amino
acids dynamics) between two dairy-based drinks containing casein and matched on
macronutrient composition but differing in mineral composition.
Study design
Randomized cross-over study with two treatments
Intervention
The subjects will drink two 600ml dairy-based drinks containing casein and
matched on macronutrient composition but differing in mineral composition.
Study burden and risks
The risks associated with participation are negligible, as both phlebotomy and
MRI are eminently safe medical techniques, and the
stimuli consist of normally consumed food products. The burden associated with
participation consists of two visits, which both
require an overnight fast, 13 blood draws (10 mL per draw, totalling 80 mL) and
multiple MRI scans over the period of 1 hours. These
may all cause minimal discomfort. These is no benefit to participation for the
participants, the group is only related insofar as they
are healthy males.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
* Male
* 18 - 55 yr old
* In self-reported health
* BMI between 18,5 and 25kg/m2
Exclusion criteria
* Bovine milk allergy or intolerance (self-reported)
* Being vegan
* Lactose intolerance (self-reported)
* Disorders of the upper ingestive tract resulting in difficulties
chewing/swallowing.
* Unexplained weight change
* Gastric disorders or regular gastric complaints, heart burn for example
* Use of proton pump inhibitors or other medication which alters the normal
function-ing of the stomach
* Use of a 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.
* Use of a medical drug use that influence the GI tract*s microbiota:
antibiotic use within 1 months prior to the pre-study screenings day
* Use of recreational drugs within 1 month prior to the pre-study screenings
day
* Alcohol consumption of more than 14 glasses/week
* Smoking
* Having a contra-indication to MRI scanning (including, but not limited to):
* Pacemakers and defibrillators
* Intraorbital or intraocular metallic fragments
* Ferromagnetic implants
* Claustrofobic
* Not wanting information at unexpected findings
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 | NL71177.081.19 |
| Other | Zal parallel worden geregistreerd in Dutch Trial register |
| OMON | NL-OMON20073 |