Healthy Male Volunteers Over 65NCT06971822
Assessing the Impact of a Leucine Enriched Whey Protein vs Isonitrogenous Whey on Muscle Protein Synthetic Responses in the Rested and Acute Post Exercise States in Older Adults
A study testing Protein Supplementation in people with Healthy Male Volunteers Over 65, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Occupying ~45-55% of body mass, skeletal muscle is the largest organ of the body and plays a pivotal role in locomotion, structural support and whole-body metabolic health. Additionally, skeletal muscle serves as the largest reservoir of amino acids (AA), which negatively adapts in states of disease and fasting to… Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers Over 65
- What is being tested?
- Protein Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2025to 28 Feb 2029
- 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 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- A BMI <18 or >35 kg/m2
- Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke
- Any metabolic disease
- Clotting dysfunction
- A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
- Lactose intolerance
- 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.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital Medical School
Derby, Derbyshire, DE22 3NE
Jake Cox, 07731 755075, mbyjc16@nottingham.ac.uk
Philip J Atherton
About this study
Occupying ~45-55% of body mass, skeletal muscle is the largest organ of the body and plays a pivotal role in locomotion, structural support and whole-body metabolic health. Additionally, skeletal muscle serves as the largest reservoir of amino acids (AA), which negatively adapts in states of disease and fasting to provide energy and AAs for vital organs, but also positively adapts to nutrition (i.e. protein consumption) and exercise (i.e. resistance exercise (RE)). With the current global ageing population, pressure on health and social care systems is continuing to mount due to increased frailty and other age-related co-morbidities. Sarcopenia, the loss of muscle mass (atrophy) and function with advancing age, predisposes an individual to an increased likelihood of physical disability, falls/fractures and mortality. Whilst sarcopenia is multifaceted and has no sole cause, reduced responses to environmental stimuli (namely nutrition (i.e. protein feeding) and exercise) termed "anabolic resistance", appears to be a governing role in the progression of age-related muscle atrophy. The maintenance of muscle mass is regulated by the dynamic relationship between muscle protein synthesis (MPS) and muscle protein breakdown (MPB) with anabolic resistance, therefore, centering upon the blunting of increases in MPS and/or suppression of MPB.
Aged muscle has consistently shown depressed MPS rates following feeding and also exercise when compared to young muscle. Additionally, older individuals need to consume a greater amount of protein compared to younger individuals to drive an MPS increase above baseline levels. This can often prove difficult due to older adults exhibiting increased satiety, likely contributing to the inadequate daily consumption of protein in such populations. Fortifying protein with leucine may, therefore, provide a nutraceutical avenue for combating anabolic resistance in ageing muscle. Leucine, both an essential amino acid (EAA) and branched chain amino acid (BCAA), is the key AA for stimulating MPS via activation of mechanistic target of rapamycin complex 1 (mTORC1), meaning protein rich in leucine may be advantageous to trigger MPS. Recent work has shown that a submaximal protein (10 g) drink enriched with leucine (4.5 g), compared to the non-essential amino acid (NEAA)- alanine (4.5 g), elevated MPS in older individuals, with anabolic signalling also being robustly triggered when administering ~6g BCAAs contain ~2.6 g leucine in older adults. However, research has also shown that in the absence of a full AA profile, leucine alone failed to stimulate MPS in postmenopausal women. It, therefore, remains inconclusive whether standalone or adjuvant supplementation of leucine is most effective to sufficiently stimulate MPS across aged populations and it remains to be investigated whether submaximal doses of complete protein enriched with leucine may lead to enhanced muscle anabolism in older adults.
In this study, we aim to assess the impact of dietary supplementation with a "super-whey" (SW) protein (with ~40% enhanced leucine and ~20% enhanced EAAs) vs. isonitrogenous whey protein (WP) on muscle protein synthesis (MPS). We will examine these effects both in the rested state, as well as the 24 hour post-exercise period under tightly controlled activity and feeding conditions.
- Conditions
- Healthy Male Volunteers Over 65
- Being tested
- Protein Supplementation
- Keywords
- Leucine, Muscle Mass, Sarcopenia, Nutrition, Protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein SupplementationDietary supplement
We are assessing the supplementation of a controlled diet with beta-lactoglobulin protein compared to regular isonitrogenous whey protein. We will make these comparisons over both the 24 hour rested and 24 hour post-exercise states. Beta-lactoglobulin has a higher leucine content than traditional whey protein, with this leucine amino acid thought to have a critical role as an anabolic stimulus to initiate muscle protein synthesis.
| Study group | Role | What they receive |
|---|---|---|
| Isonitrogenous Whey Protein Group | Active comparator | This group will receive a 20g supplement of isonitrogenous whey protein supplement with each of their controlled meals on the study visits. Receives: Dietary Supplement: Protein Supplementation |
| BLG | Experimental | This group will receive a 20g supplement of BLG (leucine enriched protein) supplement with each of their controlled meals on the study visits. Receives: Dietary Supplement: Protein Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
We measure myofibrillar fractional synthesis rates (FSR) based on the incorporation of deuterated hydrogen from heavy water (D2O) in the muscle. Participants will consume the heavy water the day before the onset of the study, and then muscle biopsies will be taken at various points over the next three days for rested and post-exercise muscle protein synthesis measures.
Measured: From enrollment there is a three day lead in to the study with a controlled diet and limited physical activity, followed by two and a half days of study visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start14 Mar 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male Volunteers Over 65Studies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Atherton, University of Nottingham
- Investigators
- Philip J Atherton, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971822
- Sponsor's protocol ID
- AFI3- FMHS 63-0125
- Status last verified
- Mar 2026
- First submitted
- 6 May 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Leucine Enriched Whey Protein vs Isonitrogenous Whey on Muscle Protein Synthetic Responses in the Rested and Acute Post Exercise States in Older Adults
- ClinicalTrials.gov ID
- NCT06971822
- Acronym / sponsor ID
- AFI3- FMHS 63-0125
- Conditions
- Healthy Male Volunteers Over 65
- Keywords
- Leucine, Muscle Mass, Sarcopenia, Nutrition, Protein
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 14 May 2025 (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.
Occupying ~45-55% of body mass, skeletal muscle is the largest organ of the body and plays a pivotal role in locomotion, structural support and whole-body metabolic health. Additionally, skeletal muscle serves as the largest reservoir of amino acids (AA), which negatively adapts in states of disease and fasting to provide energy and AAs for vital organs, but also positively adapts to nutrition (i.e. protein consumption) and exercise (i.e. resistance exercise (RE)). With the current global ageing population, pressure on health and social care systems is continuing to mount due to increased frailty and other age-related co-morbidities. Sarcopenia, the loss of muscle mass (atrophy) and function with advancing age, predisposes an individual to an increased likelihood of physical disability, falls/fractures and mortality. Whilst sarcopenia is multifaceted and has no sole cause, reduced responses to environmental stimuli (namely nutrition (i.e. protein feeding) and exercise) termed "anabolic resistance", appears to be a governing role in the progression of age-related muscle atrophy. The maintenance of muscle mass is regulated by the dynamic relationship between muscle protein synthesis (MPS) and muscle protein breakdown (MPB) with anabolic resistance, therefore, centering upon the blunting of increases in MPS and/or suppression of MPB.
Aged muscle has consistently shown depressed MPS rates following feeding and also exercise when compared to young muscle. Additionally, older individuals need to consume a greater amount of protein compared to younger individuals to drive an MPS increase above baseline levels. This can often prove difficult due to older adults exhibiting increased satiety, likely contributing to the inadequate daily consumption of protein in such populations. Fortifying protein with leucine may, therefore, provide a nutraceutical avenue for combating anabolic resistance in ageing muscle. Leucine, both an essential amino acid (EAA) and branched chain amino acid (BCAA), is the key AA for stimulating MPS via activation of mechanistic target of rapamycin complex 1 (mTORC1), meaning protein rich in leucine may be advantageous to trigger MPS. Recent work has shown that a submaximal protein (10 g) drink enriched with leucine (4.5 g), compared to the non-essential amino acid (NEAA)- alanine (4.5 g), elevated MPS in older individuals, with anabolic signalling also being robustly triggered when administering ~6g BCAAs contain ~2.6 g leucine in older adults. However, research has also shown that in the absence of a full AA profile, leucine alone failed to stimulate MPS in postmenopausal women. It, therefore, remains inconclusive whether standalone or adjuvant supplementation of leucine is most effective to sufficiently stimulate MPS across aged populations and it remains to be investigated whether submaximal doses of complete protein enriched with leucine may lead to enhanced muscle anabolism in older adults.
In this study, we aim to assess the impact of dietary supplementation with a "super-whey" (SW) protein (with ~40% enhanced leucine and ~20% enhanced EAAs) vs. isonitrogenous whey protein (WP) on muscle protein synthesis (MPS). We will examine these effects both in the rested state, as well as the 24 hour post-exercise period under tightly controlled activity and feeding conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isonitrogenous Whey Protein Group | Active comparator | Dietary Supplement: Protein SupplementationThis group will receive a 20g supplement of isonitrogenous whey protein supplement with each of their controlled meals on the study visits. |
| BLG | Experimental | Dietary Supplement: Protein SupplementationThis group will receive a 20g supplement of BLG (leucine enriched protein) supplement with each of their controlled meals on the study visits. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- A BMI <18 or >35 kg/m2
- Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke
- Any metabolic disease
- Clotting dysfunction
- A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
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 |
|---|---|---|
| Protein SupplementationWe are assessing the supplementation of a controlled diet with beta-lactoglobulin protein compared to regular isonitrogenous whey protein. We will make these comparisons over both the 24 hour rested and 24 hour post-exercise states. Beta-lactoglobulin has a higher leucine content than traditional whey protein, with this leucine amino acid thought to have a critical role as an anabolic stimulus to initiate muscle protein synthesis. | Dietary supplement | BLG, Isonitrogenous Whey Protein Group |
Primary outcome
Muscle Protein Synthesis
Time frame: From enrollment there is a three day lead in to the study with a controlled diet and limited physical activity, followed by two and a half days of study visits.
We measure myofibrillar fractional synthesis rates (FSR) based on the incorporation of deuterated hydrogen from heavy water (D2O) in the muscle. Participants will consume the heavy water the day before the onset of the study, and then muscle biopsies will be taken at various points over the next three days for rested and post-exercise muscle protein synthesis measures.
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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.
Philip J Atherton 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 Protein Supplementation in people with Healthy Male Volunteers Over 65, 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 0 inclusion and 7 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 28 Apr 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 Jake Cox (07731 755075, mbyjc16@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 (time frame: From enrollment there is a three day lead in to the study with a controlled diet and limited physical activity, followed by two and a half days of study visits.). 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 28 Apr 2026.