Muscle Protein SynthesisNCT06567665
Leucine Supplementation Strategies to Enhance Muscle Anabolic Responses in Older Age
A study testing Leucine in people with Muscle Protein Synthesis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Sarcopenia describes the progressive decline of muscle mass and strength with advancing age and is associated with increased frailty and morbidity, however we do not currently have an effective treatment. 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
- Muscle Protein Synthesis
- What is being tested?
- Leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2024to 5 Aug 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 65 to 75 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male, 65-75 years of age
- BMI 18-28 kg/m2
- Non smoker
- Not performing regular resistance type exercise
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- A BMI <18 or >28 kg·m-2
- Active cardiovascular disease: uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
- Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
- Respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease (COPD)
- Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes (treated and untreated), inborn/ congenital errors of metabolism (e.g. phenylketonuria (PKU), galactosaemia)
- Active inflammatory bowel disease
Show all 14Show fewer
- Acute infection
- Acute or chronic renal disease
- Malignancy (or history of malignancy with 5 y)
- Recent steroid treatment (within 6 mo), or hormone replacement therapy
- Coagulopathy
- Musculoskeletal or neurological disorders
- Known allergies to any of the product ingredients
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew Brook, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
Joanne Mallinson, PhD, 01158219107, joanne.mallinson@nottingham.ac.uk
About this study
Sarcopenia describes the progressive decline of muscle mass and strength with advancing age and is associated with increased frailty and morbidity, however we do not currently have an effective treatment. Protein feeding and exercise is known to increase muscle mass, but aged muscle shows a lower response to these stimuli leading to muscle loss over time. We do know that ingesting leucine, a building block of protein, can overcome this reduced response to protein feeding and exercise leading to increased muscle mass in older people. However, we do not understand when the optimum time to ingest leucine is to maximise muscle mass after exercise in older people. In this study we will examine the effect of feeding leucine after exercise either with a meal or between meals.
- Conditions
- Muscle Protein Synthesis
- Being tested
- Leucine
- Keywords
- Aging, Muscle protein synthesis, Leucine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucineDietary supplement
Leucine is a dietary supplement that can be easily purchased over the counter at health food stores. It is an essential amino acid and is involved in stimulate muscle protein synthesis.
| Study group | Role | What they receive |
|---|---|---|
| Leucine supplementation between meals | Experimental | Volunteers will take leucine supplements between breakfast and lunch, between lunch and dinner, and between dinner and supper. Receives: Dietary Supplement: Leucine |
| Leucine supplementation with meals | Experimental | Volunteers will take leucine supplements with breakfast, with lunch and with dinner. Receives: Dietary Supplement: Leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis in response to leucine feeding
To quantify muscle protein synthesis in response to feeding leucine with a meal or in-between meals using mass spectrometry.
Measured: 7 days
Secondary outcomes (1)
Measure muscle anabolic and catabolic signalling pathways in response to leucine feeding
To determine the impacts of leucine feeding timings on muscle anabolic and catabolic signalling pathways using western blotting techniques.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start5 Aug 2024
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle Protein SynthesisStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Brook, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567665
- Sponsor's protocol ID
- 23046
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell WK, Williams J, Atherton P, Larvin M, Lund J, Narici M. Sarcopenia, dynapenia, and the impact of advancing age on human skeletal muscle size and strength; a quantitative review. Front Physiol. 2012 Jul 11;3:260. doi: 10.3389/fphys.2012.00260. eCollection 2012.
PubMed 22934016Atherton PJ, Smith K. Muscle protein synthesis in response to nutrition and exercise. J Physiol. 2012 Mar 1;590(5):1049-57. doi: 10.1113/jphysiol.2011.225003. Epub 2012 Jan 30.
PubMed 22289911Wilkinson DJ, Bukhari SSI, Phillips BE, Limb MC, Cegielski J, Brook MS, Rankin D, Mitchell WK, Kobayashi H, Williams JP, Lund J, Greenhaff PL, Smith K, Atherton PJ. Effects of leucine-enriched essential amino acid and whey protein bolus dosing upon skeletal muscle protein synthesis at rest and after exercise in older women. Clin Nutr. 2018 Dec;37(6 Pt A):2011-2021. doi: 10.1016/j.clnu.2017.09.008. Epub 2017 Sep 23.
PubMed 29031484Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. A high proportion of leucine is required for optimal stimulation of the rate of muscle protein synthesis by essential amino acids in the elderly. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E381-7. doi: 10.1152/ajpendo.00488.2005. Epub 2006 Feb 28.
PubMed 16507602Brook MS, Wilkinson DJ, Mitchell WK, Lund JN, Phillips BE, Szewczyk NJ, Greenhaff PL, Smith K, Atherton PJ. Synchronous deficits in cumulative muscle protein synthesis and ribosomal biogenesis underlie age-related anabolic resistance to exercise in humans. J Physiol. 2016 Dec 15;594(24):7399-7417. doi: 10.1113/JP272857. Epub 2016 Nov 7.
PubMed 27654940
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leucine Supplementation Strategies to Enhance Muscle Anabolic Responses in Older Age
- ClinicalTrials.gov ID
- NCT06567665
- Acronym / sponsor ID
- 23046
- Conditions
- Muscle Protein Synthesis
- Keywords
- Aging, Muscle protein synthesis, Leucine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 23 Aug 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.
Sarcopenia describes the progressive decline of muscle mass and strength with advancing age and is associated with increased frailty and morbidity, however we do not currently have an effective treatment. Protein feeding and exercise is known to increase muscle mass, but aged muscle shows a lower response to these stimuli leading to muscle loss over time. We do know that ingesting leucine, a building block of protein, can overcome this reduced response to protein feeding and exercise leading to increased muscle mass in older people. However, we do not understand when the optimum time to ingest leucine is to maximise muscle mass after exercise in older people. In this study we will examine the effect of feeding leucine after exercise either with a meal or between meals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucine supplementation between meals | Experimental | Dietary Supplement: LeucineVolunteers will take leucine supplements between breakfast and lunch, between lunch and dinner, and between dinner and supper. |
| Leucine supplementation with meals | Experimental | Dietary Supplement: LeucineVolunteers will take leucine supplements with breakfast, with lunch and with dinner. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male, 65-75 years of age
- BMI 18-28 kg/m2
- Non smoker
- Not performing regular resistance type exercise
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (14 listed)
- A BMI <18 or >28 kg·m-2
- Active cardiovascular disease: uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
- Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
- Respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease (COPD)
- Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes (treated and untreated), inborn/ congenital errors of metabolism (e.g. phenylketonuria (PKU), galactosaemia)
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 |
|---|---|---|
| LeucineLeucine is a dietary supplement that can be easily purchased over the counter at health food stores. It is an essential amino acid and is involved in stimulate muscle protein synthesis. | Dietary supplement | Leucine supplementation between meals, Leucine supplementation with meals |
Primary outcome
Muscle protein synthesis in response to leucine feeding
Time frame: 7 days
To quantify muscle protein synthesis in response to feeding leucine with a meal or in-between meals using mass spectrometry.
1 secondary outcome
Measure muscle anabolic and catabolic signalling pathways in response to leucine feeding
Time frame: 7 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 4 May 2026.
- Background: PubMed 22934016Mitchell WK, Williams J, Atherton P, Larvin M, Lund J, Narici M. Sarcopenia, dynapenia, and the impact of advancing age on human skeletal muscle size and strength; a quantitative review. Front Physiol. 2012 Jul 11;3:260. doi: 10.3389/fphys.2012.00260. eCollection 2012.
- Background: PubMed 22289911Atherton PJ, Smith K. Muscle protein synthesis in response to nutrition and exercise. J Physiol. 2012 Mar 1;590(5):1049-57. doi: 10.1113/jphysiol.2011.225003. Epub 2012 Jan 30.
- Background: PubMed 29031484Wilkinson DJ, Bukhari SSI, Phillips BE, Limb MC, Cegielski J, Brook MS, Rankin D, Mitchell WK, Kobayashi H, Williams JP, Lund J, Greenhaff PL, Smith K, Atherton PJ. Effects of leucine-enriched essential amino acid and whey protein bolus dosing upon skeletal muscle protein synthesis at rest and after exercise in older women. Clin Nutr. 2018 Dec;37(6 Pt A):2011-2021. doi: 10.1016/j.clnu.2017.09.008. Epub 2017 Sep 23.
- Background: PubMed 16507602Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. A high proportion of leucine is required for optimal stimulation of the rate of muscle protein synthesis by essential amino acids in the elderly. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E381-7. doi: 10.1152/ajpendo.00488.2005. Epub 2006 Feb 28.
- Background: PubMed 27654940Brook MS, Wilkinson DJ, Mitchell WK, Lund JN, Phillips BE, Szewczyk NJ, Greenhaff PL, Smith K, Atherton PJ. Synchronous deficits in cumulative muscle protein synthesis and ribosomal biogenesis underlie age-related anabolic resistance to exercise in humans. J Physiol. 2016 Dec 15;594(24):7399-7417. doi: 10.1113/JP272857. Epub 2016 Nov 7.
- Individual participant dataSharing planned: No
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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.
Matthew Brook, PhD contact
Matthew Brook, 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 Leucine in people with Muscle Protein Synthesis, 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 5 inclusion and 14 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 4 May 2026. 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?
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 Joanne Mallinson, PhD (01158230127, joanne.mallinson@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis in response to leucine feeding (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567665, which also lists 5 linked publications.
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 4 May 2026.