The aim of this research is to find out more about the speed at which different types of proteins are digested and absorbed into the blood. This is important because differences in the rate of digestion and absorption can affect the nutritional…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Biobeschikbaarheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sub-study Plantino I:
Relative content of amino acids in dietary protein and relative amount of amino
acids appearing in the blood for the 4 hour period after the ingestion of
product A or B versus product C or D and for product A versus product B:
amino acid (x) content product A [g/100g protein] / amino acid (x) content
product C [g/100g protein]
and
amino acid (x) iAUC0-240 product A [µmol/L*min] / amino acid (x) iAUC0-240
product C [µmol/L*min]
amino acid (x) content product A [g/100g protein] / amino acid (x) content
product D [g/100g protein]
and
amino acid (x) iAUC0-240 product A [µmol/L*min] / amino acid (x) iAUC0-240
product D [µmol/L*min]
amino acid (x) content product B [g/100g protein] / amino acid (x) content
product C [g/100g protein]
and
amino acid (x) iAUC0-240 product B [µmol/L*min] / amino acid (x) iAUC0-240
product C [µmol/L*min]
amino acid (x) content product B [g/100g protein] / amino acid (x) content
product D [g/100g protein]
and
amino acid (x) iAUC0-240 product B [µmol/L*min] / amino acid (x) iAUC0-240
product D [µmol/L*min]
amino acid (x) content product A [g/100g protein] / amino acid (x) content
product B [g/100g protein]
and
amino acid (x) iAUC0-240 product A [µmol/L*min] / amino acid (x) iAUC0-240
product B [µmol/L*min]
where amino acid (x) = leucine, isoleucine, valine, histidine, lysine,
methionine, phenylalanine, threonine, tryptophan, alanine, arginine,
asparagine, aspartic acid, glutamic acid, glutamine, glycine, serine, tyrosine,
cysteine or proline
Sub-study Plantino II:
Relative content of amino acids in dietary protein and relative amount of amino
acids appearing in the blood for the 4 hour period after the ingestion of
product E, F or G versus product D:
amino acid (x) content product E [g/100g protein] / amino acid (x) content
product D [g/100g protein]
and
amino acid (x) iAUC0-240 product E [µmol/L*min] / amino acid (x) iAUC0-240
product D [µmol/L*min]
amino acid (x) content product F [g/100g protein] / amino acid (x) content
product D [g/100g protein]
and
amino acid (x) iAUC0-240 product F [µmol/L*min] / amino acid (x) iAUC0-240
product D [µmol/L*min]
amino acid (x) content product G [g/100g protein] / amino acid (x) content
product D [g/100g protein]
and
amino acid (x) iAUC0-240 product G [µmol/L*min] / amino acid (x) iAUC0-240
product D [µmol/L*min]
where amino acid (x) = leucine, isoleucine, valine, histidine, lysine,
methionine, phenylalanine, threonine, tryptophan, alanine, arginine,
asparagine, aspartic acid, glutamic acid, glutamine, glycine, serine, tyrosine,
cysteine or proline
- Postprandial serum concentrations of individual amino acids leucine,
isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine,
tryptophan, alanine, arginine, asparagine, aspartic acid, glutamic acid,
glutamine, glycine, serine, tyrosine, cysteine and proline over time
and for each amino acid:
o iAUC0-240 [µmol/L*min]
o iCmax [µmol/L]
o Tmax [1]
- In Sub-study Plantino I: Relative content of amino acids in dietary protein
and relative amount of amino acids appearing in the blood expressed as iCmax
after the ingestion of product A or B versus product C or D and for product A
vs product B:
amino acid (x) content product A [g/100g protein] / amino acid (x) content
product C [g/100g protein]
and
amino acid (x) iCmax product A [µmol/L] / amino acid (x) iCmax product C [µmol/
L]
and similar for product A versus product D, product B versus product C, product
B versus product D and product A versus product B
where amino acid (x) = leucine, isoleucine, valine, histidine, lysine,
methionine, phenylalanine, threonine, tryptophan, alanine, arginine,
asparagine, aspartic acid, glutamic acid, glutamine, glycine, serine, tyrosine,
cysteine or proline
- In Sub-study Plantino II: Relative content of amino acids in dietary protein
and relative amount of amino acids appearing in the blood expressed as iCmax
after the ingestion of product E, F or G versus product D:
amino acid (x) content product E [g/100g protein] / amino acid (x) content
product D [g/100g protein]
and
amino acid (x) iCmax product E [µmol/L] / amino acid (x) iCmax product D [µmol/
L]
and similar for product F versus product D and product G versus product D
where amino acid (x) = leucine, isoleucine, valine, histidine, lysine,
methionine, phenylalanine, threonine, tryptophan, alanine, arginine,
asparagine, aspartic acid, glutamic acid, glutamine, glycine, serine, tyrosine,
cysteine or proline
Secondary outcome
Demographics and subject characteristics
Parameters for describing demographics and subject characteristics in this
study are:
- Sex [male/female]
- Age [years]
Anthropometry
- Body weight [kg]
- Height [m]
- Calculated BMI [kg/m2]
Relevant medical history
Relevant prior and concomitant medication, nutritional supplements and medical
interventions
- Relevant prior and concomitant medication
- Prior and concomitant nutritional supplements
- Medical interventions
Product compliance
- Time for study product intake: start time study product intake [hour:minutes]
and end time study product intake [hour:minutes]
- Non-compliance with product intake: less than 100% of the product
Protocol compliance
- Adherence to instructions and restrictions
Background summary
The use of plant-based proteins in the daily diet is increasing and the demand
for plant-based variants is also increasing for medical nutrition products.
plant-based proteins have a different amino acid composition than proteins from
animal sources, such as dairy protein. In the future, the use of plant-based
proteins in medical nutrition can (partially) replace the use of dairy
proteins, resulting in a lower burden on the environment.
Study objective
The aim of this research is to find out more about the speed at which different
types of proteins are digested and absorbed into the blood. This is important
because differences in the rate of digestion and absorption can affect the
nutritional status of patients requiring medical nutrition.
Study design
This is a randomised controlled, double blind, crossover, single-centre
exploratory study.
In order to limit the number of study visits and thereby the burden for each
subject as well as to limit the number of product comparisons, the study will
be conducted as two consecutive sub-studies with exactly the same set-up
(sub-study Plantino I and Plantino II).
Intervention
Test products:
Sub-study Plantino I: 4 protein solutions: 2 x 100% dairy protein and 2x
combination of dairy protein and plant-based protein
Sub-study Plantino II study: 4 protein solutions: 1 x 100% dairy protein and 3x
100% plant-based protein
Study burden and risks
The following description will be performed for sub-study Plantino I and II.
After a screening visit, subjects must take a study product, a total of 4 times
during 4 study visits. During a study visit, 1 product is taken each time.
Blood will be drawn at 14 times during 4.5 hours. A follow-up call appointment
will take place a few days after the last study visit.
During participation, subjects must adhere to a number of rules related to
medication use and lifestyle. The study is conducted with healthy adults and
subjects take a single food product at each study visit that is expected to
cause no discomfort to the subject. The risks of the other study activities are
very limited; there is a small risk of pain/discomfort during the blood draw.
The burden of this study on subjects is considered to be low and the benefits
of gaining more knowledge about the properties of the food products outweigh
the low burden.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 and <= 70 years
2. Body Mass Index (BMI) >= 18.5 and <= 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health
Exclusion criteria
1. Any gastrointestinal (GI) disease or surgery that may interfere with GI
function and/or protein metabolism, including but not limited to
phenylketonuria, pancreatitis, short bowel syndrome, celiac disease, Crohn*s
disease, in the opinion of the Investigator
2. Known renal or hepatic diseases that may interfere with protein metabolism,
including but not limited to acute hepatitis, chronic liver disease, nephritis,
cystinuria, chronic kidney disease, in the opinion of the Investigator
3. Use of systemic medication within the past 3 weeks prior to screening which
in the opinion of the Investigator may influence gastric acid production and/or
gastrointestinal motility or function and/or protein metabolism (for example:
antibiotics, anticonvulsants, prokinetics, antacids, opioid analgesics,
anticoagulants, corticosteroids, laxatives, growth hormone, testosterone,
immunosuppressants, or insulin).
4. Allergy to soy, pea and/or cow*s milk protein
5. Adherence to a weight loss program
6. Current eating disorder, e.g. anorexia nervosa or bulimia
7. Known pregnancy and/or lactation
8. Current smoking or stopped smoking for < 1 month prior to screening (except
for incidental smoking of <= 3 cigarettes/cigars/pipes per week on average in
the last month prior to screening)
9. Average alcohol use of > 21 glasses per week for men or > 14 glasses per
week for women (on average during the last 6 months prior to screening)
10. Drug or medicine abuse in opinion of the investigator
11. Any known bleeding disorder
12. Known difficulties with placement of and/or blood drawings from a cannula
13. Active participation in any other study with investigational or marketed
products concomitantly or within 4 weeks prior to screening
14. Major medical or major surgical event requiring hospitalization within the
preceding 3 months and/or scheduled in the period of study participation
15. Investigator*s uncertainty about the willingness or ability of the subject
to comply with the protocol requirements
16. Employees of Nutricia Research and/or their family members or relatives
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 | NL82913.056.22 |