Leucine Supplementation Strategies to Enhance Muscle Anabolic Responses in Older Age

April 28, 2026 updated by: University of Nottingham
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leucine supplementation between meals
Volunteers will take leucine supplements between breakfast and lunch, between lunch and dinner, and between dinner and supper.
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.
Experimental: Leucine supplementation with meals
Volunteers will take leucine supplements with breakfast, with lunch and with dinner.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure muscle anabolic and catabolic signalling pathways in response to leucine feeding
Time Frame: 7 days
To determine the impacts of leucine feeding timings on muscle anabolic and catabolic signalling pathways using western blotting techniques.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Matthew Brook, PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

August 5, 2026

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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