The present project characterizes the use of 15N-intrinsically-labelled milk protein as a reference-protein for development a minimal invasive method that can be used to assess protein quality in human subjects. For this purpose, our primary…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen, methodologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The ratio of isotopic enrichment (15N/13C) of (total) amino acids of the test
meal and the blood plasma as determined by (gas chromatography*) isotope ratio
mass spectrometry ((GC)-IRMS).
Secondary outcome
Measurement of total N, urea and ammonia by kinetic UV assay and 15N and 13C
enrichment by GC/IR-MS in urine will be assessed.
Background summary
The evaluation of protein quality has been identified as the top priority
question by the Food and Agricultural Organization (FAO) of the United Nations.
However, the current available methods do not precisely estimate protein
quality, or need invasive procedures. The proposed *dual tracer approach* is a
minimal invasive method to evaluate protein quality in humans.
Study objective
The present project characterizes the use of 15N-intrinsically-labelled milk
protein as a reference-protein for development a minimal invasive method that
can be used to assess protein quality in human subjects. For this purpose, our
primary objectives are to define the digestive and metabolic behaviour and
distribution of the 15N-intrinsically-labelled milk protein compared to the
internal standard 13C-spirulina
Study design
Randomized cross-over trial with two experimental meals.
Intervention
On two separate test days, subjects will receive a semi liquid meal (pudding)
divided in 9 portions, (500 Kcal; meal 1: 27 En% Protein,10 En% fat, 62 En%
carbohydrates; meal 2: 14 En% Protein,10 En% fat, 75 En% carbohydrates), made
with intrinsically labelled 15N protein powder. Furthermore, the meal will
contain a trace amount of 13C-labelled algae protein as an internal standard.
Meals will differ in the amount (e.g. 50g or 25g) of 15N-labelled milk protein.
Study burden and risks
A meal challenge with intrinsically labelled protein and addition of stable
isotope tracer is frequently used in postprandial studies. Stable isotopes are
naturally occurring isotopes and are not harmful for subjects, as there is no
decay. Furthermore, placing venous catheters and blood sampling can
occasionally cause a local haematoma or bruise and some participants may report
pain or discomfort. Subjects have to come to the research facility three times,
a screening visit of 1 hour, and 2 experimental days of 7 hours. Subjects will
be financially compensated for participation.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
* Healthy
* Age: 20 * 35 y
* BMI: 18.5 * 25 kg/m2
* Stable dietary habits
* Veins suitable for cannulation (blood sampling)
Exclusion criteria
* Having a history of medical or surgical events that may significantly affect the study outcome
* Medical drug use accept incidental use of paracetamol
* (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer , bowel disease
* Milk protein or lactose intolerance or allergy
* Alcohol consumption of >14 (women) or > 21 (men) units per week
* Drug abuse
* Moderate intense physical activity (exercise) for more than 5 hours/week
* Reported weight loss or weight gain of > 3 kg in the month prior to pre-study screening
* Reported slimming diet, or medically prescribed diet
* Having a habitual diet with a protein content of <10 En% > 30 En%
* Reported vegan or macrobiotic life-style
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 |
|---|---|
| ClinicalTrials.gov | NCTnotyetassigned |
| CCMO | NL56440.081.16 |