HealthyNCT06654986
Muscle Anabolic Response to β2-adrenergic Stimulation With Increased Amino Acid Availability.
A study testing Salmeterol + amino acid availability in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salmeterol + amino acid availability
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Oct 2024to 18 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- Physically active >5 hours a week
- Maximum oxygen uptake classified as high or very high
Who cannot join
- Active smoker currently or within the past 5 years
- Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
- Chronic or acute illness deemed by the responsible study physician to affect the test parameters
- Deviation from the study protocol
- Lean mass index >21 kg/m²
- Pregnancy
- Smoker
- Blood donation during the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen, 2100
Morten Hostrup, PhD, +4535321595, mhostrup@nexs.ku.dk
About this study
Official title: The Importance of Amino Acid Availability in Modulating the Muscle Anabolic Response to β2-adrenergic Stimulation.
The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women.
- Conditions
- Healthy
- Being tested
- Salmeterol + amino acid availability, Salmeterol + placebo, Placebo + placebo
- Keywords
- Beta2-adrenergic stimulation, Amino acid availability, Skeletal muscle hypertophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol + amino acid availabilityDrug
The participants will be administered 200 µg salmeterol (8 puffs) from a MDI device and 40 g amino acid availability (clear whey in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.
Salmeterol + placeboDrug
The participants will be administered 200 µg salmeterol (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.
Placebo + placeboDrug
The participants will be administered placebo (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol + amino acid availability | Experimental | The participants will be administered salmeterol from an inhaler device and amino acid availability (protein powder in a shaker) daily during a 6-week intervention. Receives: Drug: Salmeterol + amino acid availability |
| Salmeterol + placebo | Experimental | The participants will be administered salmeterol from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention. |
| Placebo + placebo | Placebo comparator | The participants will be administered placebo from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention. Receives: Drug: Placebo + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle hypertrophy
Muscle hypertrophy measured using Dual-energy X-ray Absorptiometry (DXA).
Measured: Through study completion, an average on 7 weeks
Secondary outcomes (3)
Quadriceps strength
Maksimal torque (Nm) achieved during isometric contraction
Measured: Through study completion, an average on 7 weeks
Power output during sprint testing
Power output measured in Watts during a sprint on a bike ergometer
Measured: Through study completion, an average on 7 weeks
Power output during time trial
Mean power output measured in Watts during a time trial on a bike ergometer
Measured: Through study completion, an average on 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start31 Oct 2024
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Model description
- Thirty-six healthy, well-trained men and women will be randomized into three distinct groups, each receiving one of the following interventions: 1) salmeterol with amino acid availability, 2) salmeterol, or 3) a placebo, administered twice daily over a 6-week intervention period. This design aims to elucidate the impact of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654986
- Sponsor's protocol ID
- SALM_chron
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Amino Acid Availability in Modulating the Muscle Anabolic Response to β2-adrenergic Stimulation.
- ClinicalTrials.gov ID
- NCT06654986
- Acronym / sponsor ID
- SALM_chron
- Conditions
- Healthy
- Keywords
- Beta2-adrenergic stimulation, Amino acid availability, Skeletal muscle hypertophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 23 Oct 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.
The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Thirty-six healthy, well-trained men and women will be randomized into three distinct groups, each receiving one of the following interventions: 1) salmeterol with amino acid availability, 2) salmeterol, or 3) a placebo, administered twice daily over a 6-week intervention period. This design aims to elucidate the impact of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation.
| Arm | Type | Receives |
|---|---|---|
| Salmeterol + amino acid availability | Experimental | Drug: Salmeterol + amino acid availabilityThe participants will be administered salmeterol from an inhaler device and amino acid availability (protein powder in a shaker) daily during a 6-week intervention. |
| Salmeterol + placebo | Experimental | –The participants will be administered salmeterol from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention. |
| Placebo + placebo | Placebo comparator | Drug: Placebo + placeboThe participants will be administered placebo from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-40
- Physically active >5 hours a week
- Maximum oxygen uptake classified as high or very high
Key exclusion criteria (8 listed)
- Active smoker currently or within the past 5 years
- Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
- Chronic or acute illness deemed by the responsible study physician to affect the test parameters
- Deviation from the study protocol
- Lean mass index >21 kg/m²
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 |
|---|---|---|
| Salmeterol + amino acid availabilityThe participants will be administered 200 µg salmeterol (8 puffs) from a MDI device and 40 g amino acid availability (clear whey in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video. | Drug | Salmeterol + amino acid availability |
| Salmeterol + placeboThe participants will be administered 200 µg salmeterol (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video. | Drug | – |
| Placebo + placeboThe participants will be administered placebo (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video. | Drug | Placebo + placebo |
Primary outcome
Skeletal muscle hypertrophy
Time frame: Through study completion, an average on 7 weeks
Muscle hypertrophy measured using Dual-energy X-ray Absorptiometry (DXA).
3 secondary outcomes
Quadriceps strength
Time frame: Through study completion, an average on 7 weeks
Power output during sprint testing
Time frame: Through study completion, an average on 7 weeks
Power output during time trial
Time frame: Through study completion, an average on 7 weeks
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 9 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmeterol + amino acid availability in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle hypertrophy (time frame: Through study completion, an average on 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 9 Apr 2025.