HealthyNCT03934632
The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
A study testing Postabsorptive, Postprandial and Immobilisation in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Postabsorptive, Postprandial and Immobilisation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2019to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-40 years of age
- Body mass index between 18.5 and 30
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
- Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism)
- A personal or family history of epilepsy, seizures or schizophrenia
- Any known disorders in muscle metabolism
- Regular use of nutritional supplements
Show all 10Show fewer
- Allergy to lidocaine
- Allergy to one or multiple amino acids
- Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture) as these could be exacerbated by the intervention e.g. unilateral leg immobilisation, or mean the participant is unable to use crutches.
- Having received or ingested a stable isotope tracer in the past
Trial locations and contacts
1 site in 1 country.
About this study
The present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation.
- Conditions
- Healthy
- Being tested
- Postabsorptive, Postprandial, Immobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostabsorptiveOther
Saline will be infused to mimic postabsorptive circulating amino acid concentrations
PostprandialOther
An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations
ImmobilisationProcedure or surgery
One leg will undergo 2 days immobilisation prior to the test day
| Study group | Role | What they receive |
|---|---|---|
| Postabsorptive | Active comparator | Saline infusion to mimic postabsorptive circulating amino acid concentrations Receives: Other: Postabsorptive; Procedure: Immobilisation |
| Postprandial | Active comparator | Amino acid infusion to mimic postprandial circulating amino acid concentrations Receives: Other: Postprandial; Procedure: Immobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein breakdown rate
Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion
Measured: 1 hour
Secondary outcomes (2)
Muscle protein breakdown rate
Muscle protein breakdown rate (FBR, measured in %/h) during 3 hours of saline or amino acid infusion
Measured: 3 hours
Muscle protein synthesis rate
Muscle protein synthesis rate (FSR, measured in %/h) during 3 hours of saline or amino acid infusion measured using a D5 phenylalanine infusion
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start15 Apr 2019
- Primary completion17 Mar 2020
- Study completion9 Jan 2023
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlou Dirks, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934632
- Sponsor's protocol ID
- 180509/B/01
- Status last verified
- Mar 2023
- First submitted
- 16 Apr 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
- ClinicalTrials.gov ID
- NCT03934632
- Acronym / sponsor ID
- 180509/B/01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 2 May 2019 (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 present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postabsorptive | Active comparator | Other: Postabsorptive, Procedure: ImmobilisationSaline infusion to mimic postabsorptive circulating amino acid concentrations |
| Postprandial | Active comparator | Other: Postprandial, Procedure: ImmobilisationAmino acid infusion to mimic postprandial circulating amino acid concentrations |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18-40 years of age
- Body mass index between 18.5 and 30
Key exclusion criteria (10 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
- Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism)
- A personal or family history of epilepsy, seizures or schizophrenia
- Any known disorders in muscle metabolism
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 |
|---|---|---|
| PostabsorptiveSaline will be infused to mimic postabsorptive circulating amino acid concentrations | Other | Postabsorptive |
| PostprandialAn amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations | Other | Postprandial |
| ImmobilisationOne leg will undergo 2 days immobilisation prior to the test day | Procedure or surgery | Postabsorptive, Postprandial |
Primary outcome
Muscle protein breakdown rate
Time frame: 1 hour
Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion
2 secondary outcomes
Muscle protein breakdown rate
Time frame: 3 hours
Muscle protein synthesis rate
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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. This study is not recruiting at the moment.
Marlou Dirks, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postabsorptive, Postprandial and Immobilisation in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
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 10 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: finished, as of the sponsor's last update on 22 Mar 2023. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein breakdown rate (time frame: 1 hour). 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 22 Mar 2023.