Old AgeAj1BNCT01890369
Modulation of Muscle Protein Metabolism by Essential Amino Acids
A study testing 15g Mixed Essential Amino Acids, 3g Leucine and 15g Mixed Essential Amino Acid REFEED in people with Old Age, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular… Read more about this study
- Who is it for?
- Ages 65 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Old Age
- What is being tested?
- 15g Mixed Essential Amino Acids, 3g Leucine and 15g Mixed Essential Amino Acid REFEED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jul 2014
- 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 65 to 75 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- 65-75yrs
- BMI 18-28
Who cannot join
- Type 2 Diabetes mellitus
- Neurological Disease
- Significant cardiac, hepatic or renal disease
- Active malignancy
- Medication inc. Corticosteroids, NSAID use, Beta adrenoblockers.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
School of Graduate Entry Medicine
Derby, DE22 3DT
William K Mitchell, MA,MB,BChir, (+44)1332 724681, kylemitchell@doctors.net.uk
William K Mitchell, MA MB BChir
About this study
The investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular mechanisms underlying this. The investigators will look at these phenomena in older men as this group is known to be subject to a gradual loss of muscle mass and strength.
Read the detailed description
Muscles can stay very constant in size for much of adult life yet dramatic wasting is seen in advanced age and ill health. A better understanding of how muscles regulate their size will help design treatments to slow wasting in disease and to promote active aging. We plan to study a group of older men, ~70yrs, the age at which muscle bulk starts to decrease, to observe how the muscles respond to feeding. We will provide a drink that contains the digested products of proteins from which muscles are built. Taking blood samples and some tiny biopsies of muscle (done under local anaesthesia) will allow us to measure muscle turnover and we will be able to measure for how long after a meal muscles actively take in nutrients before becoming "full". We will also measure how long the muscle remains "full" before it returns to a state where it can again be stimulated to take in nutrients. We will also explore if leucine, one of the component parts of protein (especially in meat and dairy products) and a food widely used supplement, can promote the early re-stimulation of muscle by eating.
- Conditions
- Old Age
- Being tested
- 15g Mixed Essential Amino Acids, 3g Leucine, 15g Mixed Essential Amino Acid REFEED
- Keywords
- Old Age, Sarcopenia, Amino Acid, Muscle
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15g Mixed Essential Amino AcidsDietary supplement
Dissolved in 250ml water.
3g LeucineDietary supplement
Dissolved in 250ml water.
15g Mixed Essential Amino Acid REFEEDDietary supplement
Dissolved in 250ml water.
| Study group | Role | What they receive |
|---|---|---|
| Early leucine refeed | Experimental | 15g Mixed Essential Amino Acids. 90 min delay. 3g Leucine Receives: Dietary Supplement: 15g Mixed Essential Amino Acids; Dietary Supplement: 3g Leucine |
| Early EAA refeed | Experimental | 15g Mixed Essential Amino Acids. 90 min delay. 15g Mixed Essential Amino Acid REFEED Receives: Dietary Supplement: 15g Mixed Essential Amino Acids; Dietary Supplement: 15g Mixed Essential Amino Acid REFEED |
| Mid latency EAA refeed | Experimental | 15g Mixed Essential Amino Acids. 150 min delay. 15g Mixed Essential Amino Acid REFEED Receives: Dietary Supplement: 15g Mixed Essential Amino Acids; Dietary Supplement: 15g Mixed Essential Amino Acid REFEED |
| Late latency EAA refeed | Experimental | 15g Mixed Essential Amino Acids. 210 min delay. 15g Mixed Essential Amino Acid REFEED Receives: Dietary Supplement: 15g Mixed Essential Amino Acids; Dietary Supplement: 15g Mixed Essential Amino Acid REFEED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar Fractional Synthetic Rate
Assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)
Measured: 6-10hrs
Secondary outcomes (3)
Leg blood flow
Common femoral bulk flow (Doppler USS)
Measured: 6-10hrs
mTORC1 and AKT phosphorylation
Western Immunoblotting
Measured: 6-10hrs
Muscle Protein Breakdown
By Arteriovenous limb balance
Measured: 6-10hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Sponsor
- Investigators
- Philip J Atherton, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890369
- Sponsor's protocol ID
- B13122012 GEM BMS
- Acronym
- Aj1B
- Status last verified
- Jan 2014
- First submitted
- 26 Jun 2013
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Muscle Protein Metabolism by Essential Amino Acids
- ClinicalTrials.gov ID
- NCT01890369
- Acronym / sponsor ID
- Aj1B / B13122012 GEM BMS
- Conditions
- Old Age
- Keywords
- Old Age, Sarcopenia, Amino Acid, Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 1 Jul 2013 (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.
The investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular mechanisms underlying this. The investigators will look at these phenomena in older men as this group is known to be subject to a gradual loss of muscle mass and strength.
Detailed description
Muscles can stay very constant in size for much of adult life yet dramatic wasting is seen in advanced age and ill health. A better understanding of how muscles regulate their size will help design treatments to slow wasting in disease and to promote active aging. We plan to study a group of older men, ~70yrs, the age at which muscle bulk starts to decrease, to observe how the muscles respond to feeding. We will provide a drink that contains the digested products of proteins from which muscles are built. Taking blood samples and some tiny biopsies of muscle (done under local anaesthesia) will allow us to measure muscle turnover and we will be able to measure for how long after a meal muscles actively take in nutrients before becoming "full". We will also measure how long the muscle remains "full" before it returns to a state where it can again be stimulated to take in nutrients. We will also explore if leucine, one of the component parts of protein (especially in meat and dairy products) and a food widely used supplement, can promote the early re-stimulation of muscle by eating.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early leucine refeed | Experimental | Dietary Supplement: 15g Mixed Essential Amino Acids, Dietary Supplement: 3g Leucine15g Mixed Essential Amino Acids. 90 min delay. 3g Leucine |
| Early EAA refeed | Experimental | Dietary Supplement: 15g Mixed Essential Amino Acids, Dietary Supplement: 15g Mixed Essential Amino Acid REFEED15g Mixed Essential Amino Acids. 90 min delay. 15g Mixed Essential Amino Acid REFEED |
| Mid latency EAA refeed | Experimental | Dietary Supplement: 15g Mixed Essential Amino Acids, Dietary Supplement: 15g Mixed Essential Amino Acid REFEED15g Mixed Essential Amino Acids. 150 min delay. 15g Mixed Essential Amino Acid REFEED |
| Late latency EAA refeed | Experimental | Dietary Supplement: 15g Mixed Essential Amino Acids, Dietary Supplement: 15g Mixed Essential Amino Acid REFEED15g Mixed Essential Amino Acids. 210 min delay. 15g Mixed Essential Amino Acid REFEED |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male
- 65-75yrs
- BMI 18-28
Key exclusion criteria (5 listed)
- Type 2 Diabetes mellitus
- Neurological Disease
- Significant cardiac, hepatic or renal disease
- Active malignancy
- Medication inc. Corticosteroids, NSAID use, Beta adrenoblockers.
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 |
|---|---|---|
| 15g Mixed Essential Amino AcidsDissolved in 250ml water. | Dietary supplement | Early EAA refeed, Early leucine refeed, Late latency EAA refeed, Mid latency EAA refeed |
| 3g LeucineDissolved in 250ml water. | Dietary supplement | Early leucine refeed |
| 15g Mixed Essential Amino Acid REFEEDDissolved in 250ml water. | Dietary supplement | Early EAA refeed, Late latency EAA refeed, Mid latency EAA refeed |
Primary outcome
Myofibrillar Fractional Synthetic Rate
Time frame: 6-10hrs
Assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)
3 secondary outcomes
Leg blood flow
Time frame: 6-10hrs
mTORC1 and AKT phosphorylation
Time frame: 6-10hrs
Muscle Protein Breakdown
Time frame: 6-10hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
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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.
Philip J Atherton, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15g Mixed Essential Amino Acids, 3g Leucine and 15g Mixed Essential Amino Acid REFEED in people with Old Age, run by University of Nottingham 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 5 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 17 Jan 2014. 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?
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?
Myofibrillar Fractional Synthetic Rate (time frame: 6-10hrs). 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 17 Jan 2014.