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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

Sponsor: University of Nottingham

NCT ID: NCT06971822

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Protein Supplementation (supplement)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Protein Supplementation — supplement: We are assessing the supplementation of a controlled diet with beta-lactoglobulin protein compared to regular isonitrogenous whey protein.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
65 Years and over
Who
Male
Number of participants
30
Started
2025-03-14
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy male volunteers over 65
  • • NA - 30 participants
  • • 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

Who can take part?

  • • Ages 65 Years and over
  • • Diagnosed with healthy male volunteers over 65
  • • Male only

Where?

  • • Derby - Royal Derby Hospital Medical School

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Healthy Male Volunteers Over 65

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What we know so far

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Eligibility at a Glance

Key info

  • Age: 65 Years and over
  • Who can join: Male only

Who cannot take part

  • ✗A BMI \<18 or \>35 kg/m2
  • ✗Any metabolic disease
  • ✗Clotting dysfunction
  • ✗A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
  • ✗Lactose intolerance
See the full criteria
Inclusion Criteria: Exclusion Criteria: * 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

Where Is This Study? (1 UK site)

Royal Derby Hospital Medical School

Derby DE22 3NE, United Kingdom

Recruiting
Site contact (verified)
Philip J AthertonPrincipal Investigator

How to Get in Touch

Jake Cox

Sponsor contact

CONTACT

07731 755075 mbyjc16@nottingham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03