Protein MetabolismPAAKONCT07556029
Optimal Protein Intake to Maximize Whole-Body Protein Balance in Healthy Adults
A study testing Amino Acid in people with Protein Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess the optimal protein intake to maximize whole-body protein net balance in healthy adults. In a randomized, double-blinded, crossover design, 12 young, healthy adult males and females aged 18-35 years, will consume a test diet consisting of free amino acid mixtures based on milk… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Amino Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-35 years
- BMI between 18.5-30 kg/m2
- Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days per week)
- No physical limitations (i.e., able to perform all activities associated with daily living independently)
Who cannot join
- Smoking
- Diagnosed musculoskeletal 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
- Females: pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6200 MD
Julia M Malowany, MSc, +31 43 388 1617, julia.malowany@mastrichtuniversity.nl
About this study
The purpose of this study is to assess the optimal protein intake to maximize whole-body protein net balance in healthy adults. In a randomized, double-blinded, crossover design, 12 young, healthy adult males and females aged 18-35 years, will consume a test diet consisting of free amino acid mixtures based on milk protein that vary in protein content 7 separate acute metabolic trials. The main study endpoint is optimal protein intake based on the lowest protein intake that maximizes whole-body protein net balance.
- Conditions
- Protein Metabolism
- Being tested
- Amino Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino AcidDietary supplement
Test diet consisting of free amino acid mixtures based on milk protein.
| Study group | Role | What they receive |
|---|---|---|
| 0.4 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
| 0.6 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
| 0.8 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
| 1.0 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
| 1.2 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
| 1.5 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
| 1.8 g protein･kg BM-1･d-1 | Experimental | Not described Receives: Dietary Supplement: Amino Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal protein intake
The optimal protein intake to maximize whole-body protein synthesis rates in healthy, young males and females based on the consumption of milk protein.
Measured: From enrolment through to study completion, minimum 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein MetabolismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject, randomized, double-blinded, crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556029
- Sponsor's protocol ID
- METC 24-031
- Other IDs
- NL87239.068.24
- Acronym
- PAAKO
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Protein Intake to Maximize Whole-Body Protein Balance in Healthy Adults
- ClinicalTrials.gov ID
- NCT07556029
- Acronym / sponsor ID
- PAAKO / METC 24-031
- Conditions
- Protein Metabolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the optimal protein intake to maximize whole-body protein net balance in healthy adults. In a randomized, double-blinded, crossover design, 12 young, healthy adult males and females aged 18-35 years, will consume a test diet consisting of free amino acid mixtures based on milk protein that vary in protein content 7 separate acute metabolic trials. The main study endpoint is optimal protein intake based on the lowest protein intake that maximizes whole-body protein net balance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Within-subject, randomized, double-blinded, crossover design
| Arm | Type | Receives |
|---|---|---|
| 0.4 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
| 0.6 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
| 0.8 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
| 1.0 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
| 1.2 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
| 1.5 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
| 1.8 g protein･kg BM-1･d-1 | Experimental | Dietary Supplement: Amino Acid |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18-35 years
- BMI between 18.5-30 kg/m2
- Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days per week)
- No physical limitations (i.e., able to perform all activities associated with daily living independently)
Key exclusion criteria (8 listed)
- Smoking
- Diagnosed musculoskeletal 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino AcidTest diet consisting of free amino acid mixtures based on milk protein. | Dietary supplement | 0.4 g protein･kg BM-1･d-1, 0.6 g protein･kg BM-1･d-1, 0.8 g protein･kg BM-1･d-1, 1.0 g protein･kg BM-1･d-1, 1.2 g protein･kg BM-1･d-1, 1.5 g protein･kg BM-1･d-1, 1.8 g protein･kg BM-1･d-1 |
Primary outcome
Optimal protein intake
Time frame: From enrolment through to study completion, minimum 7 weeks
The optimal protein intake to maximize whole-body protein synthesis rates in healthy, young males and females based on the consumption of milk protein.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luc JC van Loon, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid in people with Protein Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia M Malowany, MSc (+31 43 388 1617, julia.malowany@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal protein intake (time frame: From enrolment through to study completion, minimum 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.