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Recruiting NCT06567665

Leucine Supplementation Strategies to Enhance Muscle Anabolic Responses in Older Age

No phase Interventional Muscle Protein Synthesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leucine.
Who it may be relevant to
Registry conditions: Muscle Protein Synthesis. Basic parameters: 65 years — 75 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement Leucine
    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.

Primary outcome measures

  • Muscle protein synthesis in response to leucine feeding [Time frame: 7 days]
Secondary outcome measures (1)
  • Measure muscle anabolic and catabolic signalling pathways in response to leucine feeding [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • University of Nottingham — Nottingham

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. PMID 22934016
  • Atherton 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. PMID 22289911
  • Wilkinson 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. PMID 29031484
  • Katsanos 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. PMID 16507602
  • Brook 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. PMID 27654940

Identifiers

NCT: NCT06567665 · 23046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗