Dietary SupplementationNCT06256744
Resistance Exercise-induced Anabolism in Youths and Adults
A study testing exercise in people with Dietary Supplementation and Exercise, run by Brock University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplementation, Exercise
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy
- free of injury that would prevent resistance exercise
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Brock University
St. Catharines, Ontario, L2S3A1
Bareket Falk, PhD
About this study
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.
Read more
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.
Read the detailed description
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, possibly due to their lower levels of circulating androgens. 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 allow for the estimation of MPS in a non-invasive breath test, which is based on the retention of an essential amino acid (i.e., leucine) that is preferentially metabolized within skeletal muscle. Given that amino acids can only be 'stored' in functional body proteins with any excess being converted to energy (i.e., oxidized), this non-invasive technique is ideal to safely estimate the anabolic (i.e., growth) potential of RET in children. Indeed, similar techniques using ingested stable isotopes have been safely and successfully used in children and adolescents.
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. It is hypothesized that following a bout of RET, protein retention will be augmented in all groups compared to a non-exercised condition. However, due to a greater basal rate of leucine retention (i.e., for growth processes), the RET-induced increase will be relatively lower in the children and adolescents.
Design: The proposed study will use a cross-sectional design that will compare leucine retention at rest, as well as following a bout of resistance exercise in children, adolescents, and adults.
Procedures: Participants will be required to make three visits to the Applied Physiology Laboratory at Brock University for the completion of all procedures.
During visit 1, the participants and their guardian(s) (if under the age of 18) will be informed of all tests and procedures that will take place over the duration of the study. Written and verbal consent will be obtained from the participants and their guardians (in the case of children and adolescents) before proceeding with further questionnaires. Questionnaires screening for medical concerns, pubertal stage, athletic training practices, menarche and oral contraceptive use (for adolescent and adult females), habitual eating habits, and habitual physical activity will then be completed. Anthropometric measurements will also be performed (i.e., height, seated height, body fat composition, skinfold thickness, limb lengths, limb circumferences, muscle cross sectional area). Following questionnaires and anthropometric measurements, participants will be familiarized with the exercises to be performed in their RET session. Each participant's strength will also be tested for these exercises.
Visits 2 and 3 will serve as the experimental sessions and will consist of a RET and a rest session, done in a counterbalanced order. For these sessions, participants will arrive fasted in the morning, and will be provided with a standardized breakfast and beverage. At the beginning of the experimental sessions, participants will have their breath collected. This will be followed by RET in one of the sessions, or continued rest. A dose of L-[1-13C]leucine isotope will then be consumed based on each participant's body mass (within a protein and carbohydrate beverage) and the breath of each participant will continue to be collected for the next 5 hours (total of 11 breath samples). A small snack will be given to each participant during this breath collection period.
Resistance Exercise: Strength testing and the training protocol will involve the following exercises which will all be performed using strength training machines. The use of such equipment is considered safer than the use of free weights as there are less degrees of freedom during limb movements, preventing technical failure prior to muscular fatigue. The following exercises will be performed: seated leg press, seated overhead press, seated chest press, seated horizontal row. Exercises will be performed with techniques described by the Canadian Society for Exercise Physiology (CSEP - PATH, 2021).
The RET protocol will comprise of 3-5 sets of each exercise at 70-80% of 1RM. Each exercise will be performed until failure (i.e., until the participant can no longer complete the movement with safe technique), as this has been shown to be optimal for stimulating MPS and eliciting muscle hypertrophy. Approximately 8-15 repetitions are expected to be completed per set and ~90s of rest will be given between sets. A similar acute RET protocol has previously been shown to be a sufficient stimulus to elicit differences in leucine retention compared to rest (tested using the non-invasive breath test that will be used in the proposed study) in adults.
The participants in the proposed study will be male and female prepubertal children (~7-12 years), adolescents (~13-16 years), and adults (18-35 years).
- Conditions
- Dietary Supplementation, Exercise
- Being tested
- exercise
- Keywords
- Children, Muscle, Protein, Resistance training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Protein supplementation | Experimental | Protein supplementation Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
mass in kg
Measured: baseline in each experimental session
body height
height in cm
Measured: baseline, pre-intervention
arm circumference
arm circumference in cm
Measured: baseline in each experimental session
thigh circumference
circumference in cm
Measured: baseline in each experimental session
Skinfold thickness - triceps
skinfold thickness in mm (using Harpenden calipers)
Measured: baseline, pre-intervention
skinfold thickness - subscapula
skinfold thickness in mm (using Harpenden calipers)
Measured: baseline, pre-intervention
Body composition (BIA)
Bioelectrical impedance analysis (BIA) - percentage of body fat
Measured: baseline, pre-intervention
Muscle thickness - thigh, upper arm
muscle thickness in mm - using ultrasound system
Measured: baseline, pre-intervention
[13C]leucine in urine
concentration in microgram, using mass spectrometry
Measured: baseline and post-each experimental session. i.e., at -60 and 300 minutes
maximal strength (1RM)
maximal weight lifted/pushed in kg - seated leg press, seated overhead press, seated chest press, seated horizontal row
Measured: baseline, pre-intervention
oxygen consumption
Oxygen consumption (l/min) - using open circuit metabolic system
Measured: During the experimental session, every 30 minutes: i.e., at -60, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes.
carbon dioxide production
carbon dioxide production (l/min) - using open circuit metabolic system
Measured: During the experimental session, every 30 minutes: i.e., at -60, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes. (every 30min)
nutritional intake
Nutritional intake (carbohydrates, fats, proteins) - in g/day and as % or daily recommendation. Using Food Frequency questionnaire and 24-h recall.
Measured: baseline, pre-intervention
leisure time physical activity level
physical activity level, using the Godin-Shephard leisure time questionnaire. Minimum score is 0, with no maximum limit. Higher score reflects more physical activity
Measured: baseline, pre-intervention
Pubertal stage (children and adolescents only)
Based on secondary sex characteristics of pubertal hair (Tanner scale). Stages are 1-5, where 1 is pre-pubertal and 5 is post-pubertal
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- children, adolescents and adults
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Bareket Falk, Brock University
- Investigators
- Bareket Falk, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256744
- Sponsor's protocol ID
- BFalk
- Status last verified
- Aug 2024
- First submitted
- 28 Dec 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be available to researchers directed involved in the study
Publications
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.
PubMed 18461111Enoka RM. Muscle strength and its development. New perspectives. Sports Med. 1988 Sep;6(3):146-68. doi: 10.2165/00007256-198806030-00003.
PubMed 3055145Faigenbaum 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.
PubMed 19620931Fukunaga 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.
PubMed 1642736Granacher 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.
PubMed 21380967Lim 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.
PubMed 35389932Lloyd 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.
PubMed 24055781Malina 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.
PubMed 17119361Mazzulla 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.
PubMed 35609328Mazzulla 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.
PubMed 30258470McKinlay 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.
PubMed 29337833Mersch, 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.
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.
PubMed 25342704Evans 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.
PubMed 34569076Schoenfeld, 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise-induced Anabolism in Youths and Adults
- ClinicalTrials.gov ID
- NCT06256744
- Acronym / sponsor ID
- BFalk
- Conditions
- Dietary Supplementation, Exercise
- Keywords
- Children, Muscle, Protein, Resistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, possibly due to their lower levels of circulating androgens. 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 allow for the estimation of MPS in a non-invasive breath test, which is based on the retention of an essential amino acid (i.e., leucine) that is preferentially metabolized within skeletal muscle. Given that amino acids can only be 'stored' in functional body proteins with any excess being converted to energy (i.e., oxidized), this non-invasive technique is ideal to safely estimate the anabolic (i.e., growth) potential of RET in children. Indeed, similar techniques using ingested stable isotopes have been safely and successfully used in children and adolescents.
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. It is hypothesized that following a bout of RET, protein retention will be augmented in all groups compared to a non-exercised condition. However, due to a greater basal rate of leucine retention (i.e., for growth processes), the RET-induced increase will be relatively lower in the children and adolescents.
Design: The proposed study will use a cross-sectional design that will compare leucine retention at rest, as well as following a bout of resistance exercise in children, adolescents, and adults.
Procedures: Participants will be required to make three visits to the Applied Physiology Laboratory at Brock University for the completion of all procedures.
During visit 1, the participants and their guardian(s) (if under the age of 18) will be informed of all tests and procedures that will take place over the duration of the study. Written and verbal consent will be obtained from the participants and their guardians (in the case of children and adolescents) before proceeding with further questionnaires. Questionnaires screening for medical concerns, pubertal stage, athletic training practices, menarche and oral contraceptive use (for adolescent and adult females), habitual eating habits, and habitual physical activity will then be completed. Anthropometric measurements will also be performed (i.e., height, seated height, body fat composition, skinfold thickness, limb lengths, limb circumferences, muscle cross sectional area). Following questionnaires and anthropometric measurements, participants will be familiarized with the exercises to be performed in their RET session. Each participant's strength will also be tested for these exercises.
Visits 2 and 3 will serve as the experimental sessions and will consist of a RET and a rest session, done in a counterbalanced order. For these sessions, participants will arrive fasted in the morning, and will be provided with a standardized breakfast and beverage. At the beginning of the experimental sessions, participants will have their breath collected. This will be followed by RET in one of the sessions, or continued rest. A dose of L-[1-13C]leucine isotope will then be consumed based on each participant's body mass (within a protein and carbohydrate beverage) and the breath of each participant will continue to be collected for the next 5 hours (total of 11 breath samples). A small snack will be given to each participant during this breath collection period.
Resistance Exercise: Strength testing and the training protocol will involve the following exercises which will all be performed using strength training machines. The use of such equipment is considered safer than the use of free weights as there are less degrees of freedom during limb movements, preventing technical failure prior to muscular fatigue. The following exercises will be performed: seated leg press, seated overhead press, seated chest press, seated horizontal row. Exercises will be performed with techniques described by the Canadian Society for Exercise Physiology (CSEP - PATH, 2021).
The RET protocol will comprise of 3-5 sets of each exercise at 70-80% of 1RM. Each exercise will be performed until failure (i.e., until the participant can no longer complete the movement with safe technique), as this has been shown to be optimal for stimulating MPS and eliciting muscle hypertrophy. Approximately 8-15 repetitions are expected to be completed per set and ~90s of rest will be given between sets. A similar acute RET protocol has previously been shown to be a sufficient stimulus to elicit differences in leucine retention compared to rest (tested using the non-invasive breath test that will be used in the proposed study) in adults.
The participants in the proposed study will be male and female prepubertal children (~7-12 years), adolescents (~13-16 years), and adults (18-35 years).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- children, adolescents and adults
| Arm | Type | Receives |
|---|---|---|
| Protein supplementation | Experimental | Other: exerciseProtein supplementation |
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- healthy
- free of injury that would prevent resistance exercise
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseResistance exercise | Other | Protein supplementation |
Primary outcome
Leucine retention
Time frame: 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.
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)
15 secondary outcomes
body mass
Time frame: baseline in each experimental session
body height
Time frame: baseline, pre-intervention
arm circumference
Time frame: baseline in each experimental session
thigh circumference
Time frame: baseline in each experimental session
Skinfold thickness - triceps
Time frame: baseline, pre-intervention
skinfold thickness - subscapula
Time frame: baseline, pre-intervention
Body composition (BIA)
Time frame: baseline, pre-intervention
Muscle thickness - thigh, upper arm
Time frame: baseline, pre-intervention
[13C]leucine in urine
Time frame: baseline and post-each experimental session. i.e., at -60 and 300 minutes
maximal strength (1RM)
Time frame: baseline, pre-intervention
oxygen consumption
Time frame: During the experimental session, every 30 minutes: i.e., at -60, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes.
carbon dioxide production
Time frame: During the experimental session, every 30 minutes: i.e., at -60, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes. (every 30min)
nutritional intake
Time frame: baseline, pre-intervention
leisure time physical activity level
Time frame: baseline, pre-intervention
Pubertal stage (children and adolescents only)
Time frame: baseline, pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 18461111Behm 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.
- Background: PubMed 3055145Enoka RM. Muscle strength and its development. New perspectives. Sports Med. 1988 Sep;6(3):146-68. doi: 10.2165/00007256-198806030-00003.
- Background: PubMed 19620931Faigenbaum 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.
- Background: PubMed 1642736Fukunaga 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.
- Background: PubMed 21380967Granacher 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.
- Background: PubMed 35389932Lim 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.
- Background: PubMed 24055781Lloyd 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.
- Background: PubMed 17119361Malina 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.
- Background: PubMed 35609328Mazzulla 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.
- Background: PubMed 30258470Mazzulla 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.
- Background: PubMed 29337833McKinlay 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.
- BackgroundMersch, 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.
- Individual participant dataSharing planned: No. Data will only be available to researchers directed involved in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bareket Falk, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Dietary Supplementation and Exercise, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bareket Falk, PhD (905-688-5550 ext. 4979, bfalk@brocku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leucine retention (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256744, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.