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NCT Number: NCT05700058

Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" in Older Adults

Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research.

Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most potent AA for stimulating muscle protein synthesis (MPS; the muscle building process). Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate MPS may contribute to muscle health maintenance in older adults and reduce satiation following a meal.

This study aims to examine which of three doses of a novel leucine-enriched whey protein ("super-whey") best stimulates muscle building in older adults

Recruiting

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Key information

Age range

65 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Ageing, Metabolism and Physiology

Derby, DE22 3DT, United Kingdom

Location status: Recruiting

Location contact

Philip Atherton, Prof

CONTACT

[email protected]

+44 1332 724725

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years).
  • Participant is willing and able to give informed consent for participation in the study.
  • Participant is physically able to perform resistance exercise

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

Treatment and study plan

Dietary protein supplement

Other

3 different doses of super-whey protein supplements will be given in a randomised crossover fashion to participants

Primary outcomes

  1. Muscle protein fractional synthetic rate (postabsorptive)

    Time frame: Assessed at 3 hour mark

    Postabsorptive measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed prior to administering a protein drink to obtain muscle protein fractional synthetic rate in the fasted state.

  2. Muscle protein fractional synthetic rate (postprandial)

    Time frame: Assessed at 6 hour mark

    Postprandial measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed following administering a protein drink to obtain muscle protein fractional synthetic rate in the fed state.

Secondary outcomes

  1. Plasma amino acid concentrations

    Time frame: Assessed over 7.5 hours

    During the fasted and fed states of the study, blood samples are collected every 20 minutes to capture the plasma amino acid concentrations in the blood at that time-point (24 timepoints assessed). Future analysis using mass-spectroscopy will allow determination of the different amino acid concentrations in the blood plasma collected.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" at Rest and in Response to Acute Exercise in Older Adults

Acronym: ARLA-WHEY

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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