SarcopeniaNCT03032757
Lysosomal Movement and Anabolic Resistance
A study testing Essential amino acids in people with Sarcopenia, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with functional impairment and physical disability in the elderly. Maintenance or growth of muscle mass is mainly driven by increased muscle protein synthesis (i.e. the generation of new muscle protein) in response to exercise and feeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Essential amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2017to 30 Aug 2018
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a non-smoking male within the specified age range for each group (young; 18-35 yrs, old; 65-75 yrs)
- Have a BMI (body mass index, body weight/height in m2) between 18 and 25 kg/m2, which is considered a normal body mass index.
- Be in good general health: no cardiovascular diseases or metabolic diseases.
Who cannot join
- Health problems such as: heart disease , metabolic disease such as phenylketonuria, rheumatoid arthritis, uncontrolled hypertension, poor lung function, or any health condition that might put the participant at risk when participating in this study.
- Generalized neuromuscular disease (such as Parkinson's disease or motorneuron disease).
- Involvement in regular structured resistance exercise training at the time of the study.
- Consumption of any analgesic drugs, anti-inflammatory drugs, or medication that is known to affect protein metabolism (beta-blockers, corticosteroids, NSAIDs).
- Participants who have undergone muscle biopsy testing or isotope infusion procedures within the last 5 years.
- Allergic to lidocaine
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
School of Sport, Exercise and Rehabilitation Sciences at University of Birmingham
Birmingham, West Midlands, B152TT
William Apro, Ph.D., 0121 414 2875, w.apro@bham.ac.uk
About this study
Official title: Defining the Role of Lysosomal Movement in Age-associated Anabolic Resistance in Human Skeletal Muscle
Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with functional impairment and physical disability in the elderly. Maintenance or growth of muscle mass is mainly driven by increased muscle protein synthesis (i.e. the generation of new muscle protein) in response to exercise and feeding. However, several investigations have shown that elderly individuals have a blunted protein synthetic response following protein intake. This inability of the elderly to properly respond to growth stimuli has been termed anabolic resistance and plays a significant role in the development of sarcopenia. However, the precise mechanisms underpinning anabolic resistance are unknown.
It is well established that muscle protein synthesis at the molecular level is regulated by a cellular protein complex called mTORC1. When exposed to a growth stimulus, mTORC1 has been shown to associate with lysosomes, i.e. the intracellular organelles responsible for the breakdown of cellular proteins, and subsequently moving towards the cell periphery.
This movement of lysosome-associated mTORC1 within the cell is believed to be vital for the activation of protein synthesis, as inhibition of lysosomal movement blunts mTORC1 activation in response to amino acids. Thus, dysregulation of lysosomal movement in ageing muscle may represent an underlying mechanism in the development of anabolic resistance. However, this area of research is unexplored in the context of human skeletal muscle. The investigators hypothesize that dysregulation of lysosomal movement plays a central role in the development of age-associated skeletal muscle anabolic resistance.
- Conditions
- Sarcopenia
- Being tested
- Essential amino acids
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential amino acidsDietary supplement
240 mg essential amino acids per kg body weight dissolved in 500 ml of water provided after exercise.
| Study group | Role | What they receive |
|---|---|---|
| Resting leg of young males | Experimental | Not described Receives: Dietary Supplement: Essential amino acids |
| Exercising leg of young males | Experimental | Not described Receives: Dietary Supplement: Essential amino acids |
| Resting leg of elderly males | Experimental | Not described Receives: Dietary Supplement: Essential amino acids |
| Exercising leg of elderly males | Experimental | Not described Receives: Dietary Supplement: Essential amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysosomal movement
Changes in intracellular localization of lysosomes will be measured via immunofluorescence
Measured: ~360 minutes
Secondary outcomes (1)
Lysosomal movement in isolated muscle cells
Changes in intracellular localization of lysosomes will be measured via immunofluorescence
Measured: ~30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start12 May 2017
- Primary completion30 Aug 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Apro, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032757
- Sponsor's protocol ID
- RG_16-200
- Status last verified
- Oct 2017
- First submitted
- 19 Jan 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of Lysosomal Movement in Age-associated Anabolic Resistance in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT03032757
- Acronym / sponsor ID
- RG_16-200
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with functional impairment and physical disability in the elderly. Maintenance or growth of muscle mass is mainly driven by increased muscle protein synthesis (i.e. the generation of new muscle protein) in response to exercise and feeding. However, several investigations have shown that elderly individuals have a blunted protein synthetic response following protein intake. This inability of the elderly to properly respond to growth stimuli has been termed anabolic resistance and plays a significant role in the development of sarcopenia. However, the precise mechanisms underpinning anabolic resistance are unknown.
It is well established that muscle protein synthesis at the molecular level is regulated by a cellular protein complex called mTORC1. When exposed to a growth stimulus, mTORC1 has been shown to associate with lysosomes, i.e. the intracellular organelles responsible for the breakdown of cellular proteins, and subsequently moving towards the cell periphery.
This movement of lysosome-associated mTORC1 within the cell is believed to be vital for the activation of protein synthesis, as inhibition of lysosomal movement blunts mTORC1 activation in response to amino acids. Thus, dysregulation of lysosomal movement in ageing muscle may represent an underlying mechanism in the development of anabolic resistance. However, this area of research is unexplored in the context of human skeletal muscle. The investigators hypothesize that dysregulation of lysosomal movement plays a central role in the development of age-associated skeletal muscle anabolic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resting leg of young males | Experimental | Dietary Supplement: Essential amino acids |
| Exercising leg of young males | Experimental | Dietary Supplement: Essential amino acids |
| Resting leg of elderly males | Experimental | Dietary Supplement: Essential amino acids |
| Exercising leg of elderly males | Experimental | Dietary Supplement: Essential amino acids |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be a non-smoking male within the specified age range for each group (young; 18-35 yrs, old; 65-75 yrs)
- Have a BMI (body mass index, body weight/height in m2) between 18 and 25 kg/m2, which is considered a normal body mass index.
- Be in good general health: no cardiovascular diseases or metabolic diseases.
Key exclusion criteria (6 listed)
- Health problems such as: heart disease , metabolic disease such as phenylketonuria, rheumatoid arthritis, uncontrolled hypertension, poor lung function, or any health condition that might put the participant at risk when participating in this study.
- Generalized neuromuscular disease (such as Parkinson's disease or motorneuron disease).
- Involvement in regular structured resistance exercise training at the time of the study.
- Consumption of any analgesic drugs, anti-inflammatory drugs, or medication that is known to affect protein metabolism (beta-blockers, corticosteroids, NSAIDs).
- Participants who have undergone muscle biopsy testing or isotope infusion procedures within the last 5 years.
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 |
|---|---|---|
| Essential amino acids240 mg essential amino acids per kg body weight dissolved in 500 ml of water provided after exercise. | Dietary supplement | Exercising leg of elderly males, Exercising leg of young males, Resting leg of elderly males, Resting leg of young males |
Primary outcome
Lysosomal movement
Time frame: ~360 minutes
Changes in intracellular localization of lysosomes will be measured via immunofluorescence
1 secondary outcome
Lysosomal movement in isolated muscle cells
Time frame: ~30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential amino acids in people with Sarcopenia, run by University of Birmingham 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 6 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: status not confirmed, as of the sponsor's last update on 25 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Apro, Ph.D. (01214142875, w.apro@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysosomal movement (time frame: ~360 minutes). 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 25 Oct 2017.