Healthy MalesNEAANCT06687343
The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men
A study testing EAA Supplement, NEAA Supplement and Maltodextrin Supplement in people with Healthy Males, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Background: Protein intake is important for maintaining skeletal muscle mass. These proteins consist of a collection of small building blocks which are called amino acids. There are two types of amino acids that are needed to build muscle: essential amino acids (EAA) and non-essential amino acids (NEAA). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- What is being tested?
- EAA Supplement, NEAA Supplement and Maltodextrin Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Nov 2024to Dec 2026
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age between 18 and 35 y inclusive
- BMI between 22 and 30 kg/m2
- Non-smoker
- Having given informed consent
Who cannot join
- Participating in a structured (progressive) exercise program
- Smoker
- Diagnosed GI tract disorders or diseases
- Diagnosed musculoskeletal disorders
- Diagnosed metabolic disorders (e.g. diabetes)
- Cardiovascular disease
Show all 13Show fewer
- Hypertension (blood pressure above 140/90 mmHg)
- Donated blood 3 months prior to test day
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
- Chronic use of gastric acid suppressing medication
- Chronic use of anti-coagulants
- Any intolerance to foods included in the standardized diet intervention
- Any implants that would be a contra-indication for performing an MRI scan
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, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht
Heather Petrick, MSc, 0031883887244, h.petrick@maastrichtuniversity.nl
Luc van Loon, Prof, Dr.
About this study
Background: Protein intake is important for maintaining skeletal muscle mass. These proteins consist of a collection of small building blocks which are called amino acids. There are two types of amino acids that are needed to build muscle: essential amino acids (EAA) and non-essential amino acids (NEAA). EAAs cannot be made in the body and must be consumed through foods, while NEAAs can be made within the body. However, if NEAA are not consumed through foods, the process of making NEAA in the body costs the body energy. It is still unknown what the impact of a diet containing too few non-essential amino acids is for muscle building and the body's energy metabolism.
Objective: To determine if a diet lacking NEAA, with or without being replaced by additional EAA, influences muscle protein building and whole-body metabolism.
Read more
Study design: Randomized, parallel design, double-blind, 10-day dietary intervention study.
Study population: 45 healthy (BMI 22-30 kg/m2) young males (age: 18-35 y inclusive).
Hypothesis: It is hypothesized that a diet lacking NEAA, with or without being replaced by additional EAA, decreases muscle protein building in humans.
- Conditions
- Healthy Males
- Being tested
- EAA Supplement, NEAA Supplement, Maltodextrin Supplement
- Keywords
- muscle protein synthesis, amino acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAA SupplementDietary supplement
Dissolved in water and ingested 4 times a day
NEAA SupplementDietary supplement
Dissolved in water and ingested 4 times a day
Maltodextrin SupplementDietary supplement
Dissolved in water and ingested 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| EAA + NEAA | Active comparator | Dietary intake of both EAA and NEAA, representing a normal diet Receives: Dietary Supplement: EAA Supplement; Dietary Supplement: NEAA Supplement |
| EAA + maltodextrin | Experimental | Dietary intake of EAA, with NEAA replaced by maltodextrin Receives: Dietary Supplement: EAA Supplement; Dietary Supplement: Maltodextrin Supplement |
| EAA | Experimental | Dietary intake of EAA, with NEAA replaced by additional EAA Receives: Dietary Supplement: EAA Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated skeletal muscle protein fractional synthesis rates
Calculated by the change in deuterium labelled alanine in skeletal muscle protein
Measured: 10 days
Secondary outcomes (17)
Integrated skin protein fractional synthesis rates
Calculated by the change in deuterium labelled alanine in skin protein
Measured: 10 days
Muscle mass
Measured using Magnetic resonance imaging (MRI)
Measured: Baseline, 10 days
Body fat composition
Measured using MRI
Measured: Baseline, 10 days
Resting energy expenditure
Measured using indirect calorimetry
Measured: Baseline, 10 days
Systolic and diastolic blood pressure
Measured using automated device
Measured: Baseline, 5 days, 10 days
Resting heart rate
Measured using automated device
Measured: Baseline, 5 days, 10 days
Plasma amino acids
Measured in plasma samples
Measured: Baseline, 5 days, 10 days
Blood metabolites
Assessed in plasma and serum samples
Measured: Baseline, 5 days, 10 days
Urine metabolites
Measured in fasted urine samples
Measured: Baseline, 5 days, 10 days
Skeletal muscle mitochondrial respiration
Measured in skeletal muscle tissue collected from muscle biopsy
Measured: Baseline, 10 days
Skeletal muscle signalling pathways
Measured in skeletal muscle tissue from muscle biopsy
Measured: Baseline, 10 days
Body mass
Assessed using scale
Measured: Baseline, 5 days, 10 days
Dietary protein intake
Assessed by calculating the actual intakes from the provided diet
Measured: 10 days
Dietary fat intake
Assessed by calculating the actual intakes from the provided diet
Measured: 10 days
Dietary carbohydrate intake
Assessed by calculating the actual intakes from the provided diet
Measured: 10 days
Liver fat
Measured using MRI
Measured: Baseline, 10 days
Body lean mass composition
Measured using MRI
Measured: Baseline, 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start14 Nov 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MalesStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687343
- Sponsor's protocol ID
- NL83031.068.22 / METC22-074
- Acronym
- NEAA
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men
- ClinicalTrials.gov ID
- NCT06687343
- Acronym / sponsor ID
- NEAA / NL83031.068.22 / METC22-074
- Conditions
- Healthy Males
- Keywords
- muscle protein synthesis, amino acids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 2024 (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.
Background: Protein intake is important for maintaining skeletal muscle mass. These proteins consist of a collection of small building blocks which are called amino acids. There are two types of amino acids that are needed to build muscle: essential amino acids (EAA) and non-essential amino acids (NEAA). EAAs cannot be made in the body and must be consumed through foods, while NEAAs can be made within the body. However, if NEAA are not consumed through foods, the process of making NEAA in the body costs the body energy. It is still unknown what the impact of a diet containing too few non-essential amino acids is for muscle building and the body's energy metabolism.
Objective: To determine if a diet lacking NEAA, with or without being replaced by additional EAA, influences muscle protein building and whole-body metabolism.
Study design: Randomized, parallel design, double-blind, 10-day dietary intervention study.
Study population: 45 healthy (BMI 22-30 kg/m2) young males (age: 18-35 y inclusive).
Hypothesis: It is hypothesized that a diet lacking NEAA, with or without being replaced by additional EAA, decreases muscle protein building in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EAA + NEAA | Active comparator | Dietary Supplement: EAA Supplement, Dietary Supplement: NEAA SupplementDietary intake of both EAA and NEAA, representing a normal diet |
| EAA + maltodextrin | Experimental | Dietary Supplement: EAA Supplement, Dietary Supplement: Maltodextrin SupplementDietary intake of EAA, with NEAA replaced by maltodextrin |
| EAA | Experimental | Dietary Supplement: EAA SupplementDietary intake of EAA, with NEAA replaced by additional EAA |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Age between 18 and 35 y inclusive
- BMI between 22 and 30 kg/m2
- Non-smoker
- Having given informed consent
Key exclusion criteria (13 listed)
- Participating in a structured (progressive) exercise program
- Smoker
- Diagnosed GI tract disorders or diseases
- Diagnosed musculoskeletal disorders
- Diagnosed metabolic disorders (e.g. diabetes)
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 |
|---|---|---|
| EAA SupplementDissolved in water and ingested 4 times a day | Dietary supplement | EAA, EAA + NEAA, EAA + maltodextrin |
| NEAA SupplementDissolved in water and ingested 4 times a day | Dietary supplement | EAA + NEAA |
| Maltodextrin SupplementDissolved in water and ingested 4 times a day | Dietary supplement | EAA + maltodextrin |
Primary outcome
Integrated skeletal muscle protein fractional synthesis rates
Time frame: 10 days
Calculated by the change in deuterium labelled alanine in skeletal muscle protein
17 secondary outcomes
Integrated skin protein fractional synthesis rates
Time frame: 10 days
Muscle mass
Time frame: Baseline, 10 days
Body fat composition
Time frame: Baseline, 10 days
Resting energy expenditure
Time frame: Baseline, 10 days
Systolic and diastolic blood pressure
Time frame: Baseline, 5 days, 10 days
Resting heart rate
Time frame: Baseline, 5 days, 10 days
Plasma amino acids
Time frame: Baseline, 5 days, 10 days
Blood metabolites
Time frame: Baseline, 5 days, 10 days
Urine metabolites
Time frame: Baseline, 5 days, 10 days
Skeletal muscle mitochondrial respiration
Time frame: Baseline, 10 days
Skeletal muscle signalling pathways
Time frame: Baseline, 10 days
Body mass
Time frame: Baseline, 5 days, 10 days
Dietary protein intake
Time frame: 10 days
Dietary fat intake
Time frame: 10 days
Dietary carbohydrate intake
Time frame: 10 days
Liver fat
Time frame: Baseline, 10 days
Body lean mass composition
Time frame: Baseline, 10 days
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 24 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAA Supplement, NEAA Supplement and Maltodextrin Supplement in people with Healthy Males, 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. 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 Heather Petrick, MSc (0031883887244, h.petrick@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated skeletal muscle protein fractional synthesis rates (time frame: 10 days). 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 24 Dec 2024.