Replication study to assess dietary protein requirements in young, healthy men.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Eiwitbehoefte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the estimated average requirement (EAR) and recommended
daily allowance (RDA) for dietary protein, which will be determined using the
IAAO method by measuring 13C enrichment in expired breath and enrichment of
L-[1-13C]-phenylalanine in plasma and urine.
Secondary outcome
To determine carbon dioxide production, 13CO2 production, plasma and urine
L-[1-13C]-phenylalanine enrichments, and plasma and urine phenylalanine
concentration in a young, healthy, male population when applying the IAAO
technique.
Background summary
Dietary protein is essential for stimulating tissue renewal and growth. Current
dietary protein guidelines are based on nitrogen balance studies, but the
complexity of this method limits its widespread application to assess dietary
requirements. The minimally invasive Indicator Amino Acid Oxidation (IAAO)
technique was recently introduced as a valid way to assess dietary protein
requirements. The first human study that has applied the IAAO technique to
assess protein requirements was performed in 8 healthy adult men in 2008.
Protein requirements defined by the IAAO technique were comparable to those
defined by the nitrogen balance method. To date, this is still the only data
available on protein requirements in healthy adult men as assessed by the IAAO
technique. Therefore, purpose of this study is to perform a replication study
to assess protein requirements in healthy adult men as assessed by the IAAO
technique in a larger sample.
Study objective
Replication study to assess dietary protein requirements in young, healthy men.
Study design
Randomized, double-blinded crossover study design.
Intervention
All subjects will consume a test diet containing 0.1, 0.3, 0.6, 0.9, 1.2, 1.5,
and 1.8 g protein/kg/d during acute metabolic trials.
Study burden and risks
The burden and risks with participation are small. The risk of catheters is
minimal and includes only a small hematoma. Sampling of breath and urine does
not bring additional risks. All subjects will be contacted within 1 week after
completing the experimental trials to ask whether they experienced any
discomfort from the interventional compounds. Participants will come to the
university up to eight times: 1 screening (~2 h) and 7 experimental days (~8.5
h each). Subjects will be instructed in the two days prior to the test day not
to perform any type of intense physical activity and to consume a maintenance
diet that will be provided by the researchers. Participants will be asked to
record their daily activities in the two days prior to the first experimental
test day. There is no direct benefit to the participant, only their
contribution to the scientific knowledge about protein requirements and their
individual protein requirement.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Male
- Aged between 18-35 years
- Healthy, recreationally active (exercise at least 1 per two weeks and maximum
4 days a week)
- 18.5 <= BMI <= 30 kg/m2
- No physical limitations (i.e. able to perform all activities associated with
daily living in an independent manner).
Exclusion criteria
- Smoking
- Musculoskeletal disorders
- Metabolic disorders
- Use of any medications known to affect protein metabolism (i.e.
corticosteroids, non-steroidal anti-inflammatories, or prescribed acne
medications).
- Chronic use of gastric acid suppressing medication or anti-coagulants
- Unstable weight over the last three months
- Diagnosed GI tract disorders or diseases
- Blood donation in the past 2 months
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 | NL77716.068.21 |
| OMON | NL-OMON26694 |