- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556029
Optimal Protein Intake to Maximize Whole-Body Protein Balance in Healthy Adults (PAAKO)
April 21, 2026 updated by: Maastricht University Medical Center
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julia M Malowany, MSc
- Phone Number: +31 43 388 1617
- Email: julia.malowany@maastrichtuniversity.nl
Study Contact Backup
- Name: Jorn Trommelen, PhD
- Phone Number: +31 43 388 1617
- Email: jorn.trommelen@maastrichtuniversity.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6200 MD
- Maastricht University Medical Centre+
-
Contact:
- Julia M Malowany, MSc
- Phone Number: +31 43 388 1617
- Email: julia.malowany@mastrichtuniversity.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 0.4 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
|
Experimental: 0.6 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
|
Experimental: 0.8 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
|
Experimental: 1.0 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
|
Experimental: 1.2 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
|
Experimental: 1.5 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
|
Experimental: 1.8 g protein・kg BM-1・d-1
|
Test diet consisting of free amino acid mixtures based on milk protein.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrolment through to study completion, minimum 7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luc JC van Loon, PhD, Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
April 14, 2026
First Submitted That Met QC Criteria
April 21, 2026
First Posted (Actual)
April 29, 2026
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 21, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 24-031
- NL87239.068.24 (Other Identifier: CCMO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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