NCT06256744

Brief Summary

Resistance exercise training (RET) in children and adolescents has become a popular area of research, with a growing body of evidence supporting its use. Position and consensus statements about RET for children indicate that it is safe and effective at increasing muscular strength, improving sport performance, and mitigating injury risk. Neural and muscular mechanisms can improve muscle strength following RET. Neural factors include improved recruitment and firing of an individual's motor units, and muscular factors primarily include an increase in the size of the muscle (hypertrophy). In children, little is known about how these mechanisms relate to muscle strength. There is very little evidence of morphological changes following RET in children. Therefore, conventional wisdom is that children rely only on neural factors to improve strength following RET. Nevertheless, some studies have suggested RET-induced muscle hypertrophy in children and adolescents, indicating that with certain training protocols, children may achieve muscle growth. Hypertrophy of muscle fibres occurs when the rate of muscle protein synthesis (MPS) is greater than the rate of protein breakdown, and is enhanced with the ingestion of dietary amino acids. Due to ethical concerns with obtaining muscle samples (i.e., from muscle biopsies) in pediatric populations, MPS rates have not been previously assessed following RET in children. Recent advancements in stable-isotope methodology (specifically, leucine) allow for the estimation of MPS in a non-invasive breath test. The objective of the proposed research is to examine the effects of an acute bout of RET on leucine retention (a proxy for MPS) in children, adolescents, and adults using a non-invasive breath test.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

First Submitted

Initial submission to the registry

December 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

December 28, 2023

Last Update Submit

August 14, 2024

Conditions

Keywords

ChildrenMuscleProteinResistance training

Outcome Measures

Primary Outcomes (1)

  • Leucine retention

    retention is calculated as intake minus leucine in expired air (mg). This test involves blowing into a breath collection bag before, and every \~30 minutes after (for \~300 minutes) ingesting a powdered-amino acid supplement (modeled after egg protein - the WHO/FAO gold standard protein source) mixed with water. The supplement will contain 0.25 g/kg body mass of protein as crystalline amino acids, 0.75 g/kg body mass of carbohydrate (\~4kcal/kg of body mass), and will be enriched with 1 mg/kg of L-\[1-13C\]leucine (Cambridge Isotope Laboratories Inc., Tewksbury, MA, USA), which is a stable isotope that can be detected in the breath of the participants when not used for protein synthesis. The amount of the isotope that is expelled (oxidized) in the breath of the participant can be detected using continuous-flow isotope ratio mass spectrometry (ID-Microbreath; Compact Science Systems, Newcastle, UK), which allows for the estimation of leucine retention (intake - oxidation)

    During the experimental session, expired air is collected pre-ingestion and every 30minutes. i.e., at -60, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes.

Secondary Outcomes (15)

  • body mass

    baseline in each experimental session

  • body height

    baseline, pre-intervention

  • arm circumference

    baseline in each experimental session

  • thigh circumference

    baseline in each experimental session

  • Skinfold thickness - triceps

    baseline, pre-intervention

  • +10 more secondary outcomes

Study Arms (1)

Protein supplementation

EXPERIMENTAL

Protein supplementation

Other: exercise

Interventions

Resistance exercise

Protein supplementation

Eligibility Criteria

Age7 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy
  • free of injury that would prevent resistance exercise

You may not qualify if:

  • consumed any medications in the past year which may affect muscle function
  • had an injury in the past 6 months that would limit the movements required for the protocols
  • been told that has diabetes
  • been told that had a heart problem
  • been told that have a breathing problem (e.g., asthma)
  • been told that sometimes experience seizures
  • had joint instability or ongoing join chronic pain
  • been told that had kidney problems
  • had stomach problems such as ulcers
  • experience prolonged bleeding after a cut

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S3A1, Canada

RECRUITING

Related Publications (15)

  • Behm DG, Faigenbaum AD, Falk B, Klentrou P. Canadian Society for Exercise Physiology position paper: resistance training in children and adolescents. Appl Physiol Nutr Metab. 2008 Jun;33(3):547-61. doi: 10.1139/H08-020.

    PMID: 18461111BACKGROUND
  • Enoka RM. Muscle strength and its development. New perspectives. Sports Med. 1988 Sep;6(3):146-68. doi: 10.2165/00007256-198806030-00003.

    PMID: 3055145BACKGROUND
  • Faigenbaum AD, Kraemer WJ, Blimkie CJ, Jeffreys I, Micheli LJ, Nitka M, Rowland TW. Youth resistance training: updated position statement paper from the national strength and conditioning association. J Strength Cond Res. 2009 Aug;23(5 Suppl):S60-79. doi: 10.1519/JSC.0b013e31819df407.

    PMID: 19620931BACKGROUND
  • Fukunaga T, Funato K, Ikegawa S. The effects of resistance training on muscle area and strength in prepubescent age. Ann Physiol Anthropol. 1992 May;11(3):357-64. doi: 10.2114/ahs1983.11.357.

    PMID: 1642736BACKGROUND
  • Granacher U, Goesele A, Roggo K, Wischer T, Fischer S, Zuerny C, Gollhofer A, Kriemler S. Effects and mechanisms of strength training in children. Int J Sports Med. 2011 May;32(5):357-64. doi: 10.1055/s-0031-1271677. Epub 2011 Mar 4.

    PMID: 21380967BACKGROUND
  • Lim C, Nunes EA, Currier BS, McLeod JC, Thomas ACQ, Phillips SM. An Evidence-Based Narrative Review of Mechanisms of Resistance Exercise-Induced Human Skeletal Muscle Hypertrophy. Med Sci Sports Exerc. 2022 Sep 1;54(9):1546-1559. doi: 10.1249/MSS.0000000000002929. Epub 2022 Apr 6.

    PMID: 35389932BACKGROUND
  • Lloyd RS, Faigenbaum AD, Stone MH, Oliver JL, Jeffreys I, Moody JA, Brewer C, Pierce KC, McCambridge TM, Howard R, Herrington L, Hainline B, Micheli LJ, Jaques R, Kraemer WJ, McBride MG, Best TM, Chu DA, Alvar BA, Myer GD. Position statement on youth resistance training: the 2014 International Consensus. Br J Sports Med. 2014 Apr;48(7):498-505. doi: 10.1136/bjsports-2013-092952. Epub 2013 Sep 20.

    PMID: 24055781BACKGROUND
  • Malina RM. Weight training in youth-growth, maturation, and safety: an evidence-based review. Clin J Sport Med. 2006 Nov;16(6):478-87. doi: 10.1097/01.jsm.0000248843.31874.be.

    PMID: 17119361BACKGROUND
  • Mazzulla M, Hodson N, West DWD, Kumbhare DA, Moore DR. A non-invasive 13CO2 breath test detects differences in anabolic sensitivity with feeding and heavy resistance exercise in healthy young males: a randomized control trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):860-870. doi: 10.1139/apnm-2021-0808. Epub 2022 May 24.

    PMID: 35609328BACKGROUND
  • Mazzulla M, Volterman KA, Packer JE, Wooding DJ, Brooks JC, Kato H, Moore DR. Whole-body net protein balance plateaus in response to increasing protein intakes during post-exercise recovery in adults and adolescents. Nutr Metab (Lond). 2018 Sep 24;15:62. doi: 10.1186/s12986-018-0301-z. eCollection 2018.

    PMID: 30258470BACKGROUND
  • McKinlay BJ, Wallace P, Dotan R, Long D, Tokuno C, Gabriel DA, Falk B. Effects of Plyometric and Resistance Training on Muscle Strength, Explosiveness, and Neuromuscular Function in Young Adolescent Soccer Players. J Strength Cond Res. 2018 Nov;32(11):3039-3050. doi: 10.1519/JSC.0000000000002428.

    PMID: 29337833BACKGROUND
  • Mersch, F., Stoboy, H., 1989. Strength training and muscle hypertrophy in children, in: Oseid, S., Carlsen, K. (Eds.), Children and Exercise XIII. Human Kinetics, Champaign, IL, pp. 165-182.

    BACKGROUND
  • Moore DR, Volterman KA, Obeid J, Offord EA, Timmons BW. Postexercise protein ingestion increases whole body net protein balance in healthy children. J Appl Physiol (1985). 2014 Dec 15;117(12):1493-501. doi: 10.1152/japplphysiol.00224.2014. Epub 2014 Oct 23.

    PMID: 25342704BACKGROUND
  • Evans WJ, Shankaran M, Smith EC, Morris C, Nyangau E, Bizieff A, Matthews M, Mohamed H, Hellerstein M. Profoundly lower muscle mass and rate of contractile protein synthesis in boys with Duchenne muscular dystrophy. J Physiol. 2021 Dec;599(23):5215-5227. doi: 10.1113/JP282227. Epub 2021 Oct 11.

    PMID: 34569076BACKGROUND
  • Schoenfeld, B., Fisher, J., Grgic, J., Haun, C., Helms, E., Phillips, S., Steele, J., Vigotsky, A., 2021. Resistance Training Recommendations to Maximize Muscle Hypertrophy in an Athletic Population: Position Stand of the IUSCA. International Journal of Strength and Conditioning 1, 1-30. https://doi.org/10.47206/ijsc.v1i1.81

    BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bareket Falk, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bareket Falk, PhD

CONTACT

Andrew McKiel, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: children, adolescents and adults
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2023

First Posted

February 13, 2024

Study Start

September 1, 2024

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Data will only be available to researchers directed involved in the study

Locations