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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Royal Derby Hospital Medical School

    Derby, Derbyshire, DE22 3NE

    Jake Cox, 07731 755075, mbyjc16@nottingham.ac.uk

    Philip J Atherton

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT06971822
Study groupRoleWhat they receive
Isonitrogenous Whey Protein GroupActive comparatorThis 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
BLGExperimentalThis 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.

  1. 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.

  1. First posted14 May 2025
  2. Study start14 Mar 2025
  3. Primary completion1 Feb 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

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)
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

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.

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