Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

3mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Progress88%

Aug 2024Aug 2026

Study Start

First participant enrolled

August 5, 2024

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

August 20, 2024

Last Update Submit

April 28, 2026

Conditions

Muscle Protein Synthesis

Keywords

AgingMuscle protein synthesisLeucine

Outcome Measures

Primary Outcomes (1)

Muscle protein synthesis in response to leucine feeding
To quantify muscle protein synthesis in response to feeding leucine with a meal or in-between meals using mass spectrometry.
7 days

Secondary Outcomes (1)

Measure muscle anabolic and catabolic signalling pathways in response to leucine feeding
7 days

Study Arms (2)

Leucine supplementation between meals

EXPERIMENTAL

Volunteers will take leucine supplements between breakfast and lunch, between lunch and dinner, and between dinner and supper.

Dietary Supplement: Leucine

Leucine supplementation with meals

EXPERIMENTAL

Volunteers will take leucine supplements with breakfast, with lunch and with dinner.

Dietary Supplement: Leucine

Interventions

LeucineDIETARY_SUPPLEMENT

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.

Leucine supplementation between mealsLeucine supplementation with meals

Eligibility Criteria

Age65 Years - 75 Years

Sexmale

Healthy VolunteersYes

Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Nottinghamlead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (5)

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: 22934016BACKGROUND
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: 22289911BACKGROUND
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. Epub 2017 Sep 23.
PMID: 29031484BACKGROUND
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: 16507602BACKGROUND
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: 27654940BACKGROUND

MeSH Terms

Interventions

Leucine

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

Matthew Brook, PhD
University of Nottingham
PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Mallinson, PhD

CONTACT

01158230127 joanne.mallinson@nottingham.ac.uk

Matthew Brook, PhD

CONTACT

matthew.brook@nottingham.ac.uk

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 23, 2024

Study Start

August 5, 2024

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

August 5, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing: Will not share

Locations

GB(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Leucine supplementation between meals

Leucine supplementation with meals

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations