Resistance ExerciseBTLPNCT06209424
Modified Breath Test to Determine Anabolic Sensitivity Across Physical Activity States
A study testing Habitual Activity, Step-Reduction and Resistance Exercise in people with Resistance Exercise and Physical Inactivity, run by University of Toronto at 1 site in Canada.
Trial summary
Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistance Exercise, Physical Inactivity, Amino Acids
- What is being tested?
- Habitual Activity, Step-Reduction and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 30 Apr 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young (age: 18-35 years)
- BMI between normal to overweight (18.5-29.9 kg/m2)
- if oral contraceptive (OC) user, must be on monophasic OCs for at least 3 months prior to study
- if non-OC user, then must have regular menstrual cycles (length: 25-35 days) for at least 3 months prior to study and at least 6 months off of OCs
Who cannot join
- Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
- Current or recent remission of cancer
- Regular use of NSAID (except low-dose aspirin), anticoagulants
- Use of prescription drugs that would impact muscle protein synthesis (e.g., Statins, Lithium, ADHD medication, etc..)
- Insertion of intrauterine device (IUD) - exception: copper
- Smoking
- Use of illicit drugs (growth hormones, testosterone)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9
Daniel R Moore, PhD, 416464088, dr.moore@utoronto.ca
Hugo JW Fung, PhD (c), 6472098764, hugojernwai.fung@utoronto.ca
About this study
Official title: Non-Invasive Modified Breath Test to Determine Anabolic Sensitivity Across Physical Activity States in Healthy Young Adults
Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. The current study aims to refine our previous breath test method to be more effective at measuring changes in how the body processes protein in different situations, such as resting, reducing physical activity, and doing resistance exercise. We hypothesize that using a lower amount of dietary amino acids in our breath test will be effective at detecting lower amounts of amino acids used after exercise, and a greater amount with step reduction compared to normal activity levels
Read the detailed description
Maintaining high-quality and abundant lean body mass (LBM) is crucial for growth, health, and performance across all ages, sexes, and activity levels. Body protein, including skeletal muscle, undergoes constant turnover, breaking down old and damaged proteins and using dietary amino acids (AA) to synthesize new proteins, especially after resistance exercise. Unused AA are oxidized for energy and excreted as carbon dioxide (CO2). Studying the proportion of AA used for protein synthesis versus energy production provides insights into acute growth of LBM after a meal in different physiological states (e.g., at rest or exercise). Stable isotope tracers, commonly administered intravenously, are used in protein metabolism research to examine the effects of nutrition and exercise on protein turnover. However, this method may not be feasible for vulnerable populations.
While exercise has been shown to enhance anabolic sensitivity (i.e., greater utilization of dietary AA for protein synthesis), step-reduction leads to fed-state anabolic resistance (I.e., reduced utilization of dietary AA for protein synthesis). Indeed, reduced habitual activity, whether mild or severe, leads to fed-state anabolic resistance, reducing the muscle protein synthesis (MPS) response to amino acids. For instance, one week of reduced daily steps (~1,192 steps/day) decreased MPS rates by approximately 27% in young males who habitually reach ~10,000 steps/day, i.e., a ~75% reduction from habitual.
Therefore, developing metabolic tools to detect anabolic resistance before muscle mass loss occurs would be valuable for both treatment and prevention of age-related muscle loss. Recently, our laboratory demonstrated the effectiveness of a non-invasive stable isotope "breath test" to detect increased anabolic sensitivity in males after resistance exercise. This study, in addition to ongoing metabolic trials in our lab, utilized a protein dose of 0.25g/kg which has been shown to maximize the rate of myofibrillar protein synthesis and to support whole-body protein synthesis. However, this dose may not adequately distinguish between more subtle changes in anabolic sensitivity. Further, a lower protein dose may reduce the duration for which breath samples would need to be collected, which would minimize participant burden and time commitment going forward.
Therefore, the present project will use previously established 'breath test' methodology but with a lower protein dose to assess the following objectives:
- To investigate whether the 'optimized' non-invasive breath test can detect changes in anabolic sensitivity (i.e., leucine oxidation) across varying physiological states (I.e., rest, step-reduction, whole-body resistance exercise) after feeding, in young healthy adults.
- To assess the reproducibility, and day-to-day variability of our breath test during habitual activity in both an at-home and a controlled laboratory setting
- Conditions
- Resistance Exercise, Physical Inactivity, Amino Acids, Dietary Protein
- Being tested
- Habitual Activity, Step-Reduction, Resistance Exercise
- Keywords
- Sex, Step-Reduction, Habitual Activity, Protein Metabolism, Resistance Exercise, Stable Isotopes, Anabolic Sensitivity
- Medical subject headings
- Sedentary Behavior, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual ActivityBehavioural
Also called Free-Living Activity
Participants will maintain habitual levels of physical activity (inclusive of structured physical activity).
Step-ReductionBehavioural
Also called Reduced Physical Activity
Participants will be required to reduce their daily step-counts to <2,000 steps/day. Further, they will be required to refrain from structured physical activity.
Resistance ExerciseBehavioural
Also called Full-Body Resistance Exercise
Participants will undergo a 50-minute resistance exercise protocol, which includes multiple sets of different exercises using weights. Each set will consist of 10 repetitions at 75% of their 1 repetition maximum (1RM). The exercises include bench press superset with lat pulldowns, overhead press superset with seated cable rows, leg press, and leg extensions with 90s rest in between sets. Before the exercise protocol, there will be a standardized 10-minute warm-up that involves cycling, leg swings, arm circles, bodyweight squats, and bench push-ups
| Study group | Role | What they receive |
|---|---|---|
| In-Person Phase | Active comparator | Habitual Activity + Resistance Exercise Metabolic Trials Receives: Behavioral: Habitual Activity; Behavioral: Resistance Exercise |
| At-Home Phase | Active comparator | Habitual Activity + Step-Reduction Metabolic Trials Receives: Behavioral: Habitual Activity; Behavioral: Step-Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exogenous Leucine Oxidation (umol/kg)
Exogenous Leucine Oxidation determined from breath 13CCO2 enrichment. Breath samples will be collected every 20-30min after test drink ingestion to determine breath 13CO2 enrichment. Total leucine oxidation will be determined from the area under the 13CO2 enrichment by time curve.
Measured: 5 hours
Net Leucine Retention (umol/kg)
Whole-Body Net Leucine Retention determined from the difference between exogenous leucine oxidation and leucine ingestion the 6 hour measurement period.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance ExerciseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Counter-Balanced Crossover Design Following familiarization, participants will be split into an in-person phase, consisting of a habitual rest and subsequent whole-body resistance exercise metabolic trials, and an at-home phase, which includes a habitual rest followed by a step-reduction metabolic trial. Participants will be randomized through a counterbalanced approach to either start with the in-person or at-home phases of our study as outlined below. Participants will be grouped by sex to ensure the same number of individuals from both males and females will undergo the in-person or at-home phases first
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Ines Kortebi, MSc, Study director, University of TorontoHugo JW Fung, PhD (c), Study chair, University of TorontoDaniel R Moore, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209424
- Sponsor's protocol ID
- 00044918
- Acronym
- BTLP
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Modified Breath Test to Determine Anabolic Sensitivity Across Physical Activity States in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06209424
- Acronym / sponsor ID
- BTLP / 00044918
- Conditions
- Resistance Exercise, Physical Inactivity, Amino Acids, Dietary Protein
- Keywords
- Sex, Step-Reduction, Habitual Activity, Protein Metabolism, Resistance Exercise, Stable Isotopes, Anabolic Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 17 Jan 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.
Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. The current study aims to refine our previous breath test method to be more effective at measuring changes in how the body processes protein in different situations, such as resting, reducing physical activity, and doing resistance exercise. We hypothesize that using a lower amount of dietary amino acids in our breath test will be effective at detecting lower amounts of amino acids used after exercise, and a greater amount with step reduction compared to normal activity levels
Detailed description
Maintaining high-quality and abundant lean body mass (LBM) is crucial for growth, health, and performance across all ages, sexes, and activity levels. Body protein, including skeletal muscle, undergoes constant turnover, breaking down old and damaged proteins and using dietary amino acids (AA) to synthesize new proteins, especially after resistance exercise. Unused AA are oxidized for energy and excreted as carbon dioxide (CO2). Studying the proportion of AA used for protein synthesis versus energy production provides insights into acute growth of LBM after a meal in different physiological states (e.g., at rest or exercise). Stable isotope tracers, commonly administered intravenously, are used in protein metabolism research to examine the effects of nutrition and exercise on protein turnover. However, this method may not be feasible for vulnerable populations.
While exercise has been shown to enhance anabolic sensitivity (i.e., greater utilization of dietary AA for protein synthesis), step-reduction leads to fed-state anabolic resistance (I.e., reduced utilization of dietary AA for protein synthesis). Indeed, reduced habitual activity, whether mild or severe, leads to fed-state anabolic resistance, reducing the muscle protein synthesis (MPS) response to amino acids. For instance, one week of reduced daily steps (~1,192 steps/day) decreased MPS rates by approximately 27% in young males who habitually reach ~10,000 steps/day, i.e., a ~75% reduction from habitual.
Therefore, developing metabolic tools to detect anabolic resistance before muscle mass loss occurs would be valuable for both treatment and prevention of age-related muscle loss. Recently, our laboratory demonstrated the effectiveness of a non-invasive stable isotope "breath test" to detect increased anabolic sensitivity in males after resistance exercise. This study, in addition to ongoing metabolic trials in our lab, utilized a protein dose of 0.25g/kg which has been shown to maximize the rate of myofibrillar protein synthesis and to support whole-body protein synthesis. However, this dose may not adequately distinguish between more subtle changes in anabolic sensitivity. Further, a lower protein dose may reduce the duration for which breath samples would need to be collected, which would minimize participant burden and time commitment going forward.
Therefore, the present project will use previously established 'breath test' methodology but with a lower protein dose to assess the following objectives:
- To investigate whether the 'optimized' non-invasive breath test can detect changes in anabolic sensitivity (i.e., leucine oxidation) across varying physiological states (I.e., rest, step-reduction, whole-body resistance exercise) after feeding, in young healthy adults.
- To assess the reproducibility, and day-to-day variability of our breath test during habitual activity in both an at-home and a controlled laboratory setting
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Counter-Balanced Crossover Design Following familiarization, participants will be split into an in-person phase, consisting of a habitual rest and subsequent whole-body resistance exercise metabolic trials, and an at-home phase, which includes a habitual rest followed by a step-reduction metabolic trial. Participants will be randomized through a counterbalanced approach to either start with the in-person or at-home phases of our study as outlined below. Participants will be grouped by sex to ensure the same number of individuals from both males and females will undergo the in-person or at-home phases first
| Arm | Type | Receives |
|---|---|---|
| In-Person Phase | Active comparator | Behavioral: Habitual Activity, Behavioral: Resistance ExerciseHabitual Activity + Resistance Exercise Metabolic Trials |
| At-Home Phase | Active comparator | Behavioral: Habitual Activity, Behavioral: Step-ReductionHabitual Activity + Step-Reduction Metabolic Trials |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy young (age: 18-35 years)
- BMI between normal to overweight (18.5-29.9 kg/m2)
- if oral contraceptive (OC) user, must be on monophasic OCs for at least 3 months prior to study
- if non-OC user, then must have regular menstrual cycles (length: 25-35 days) for at least 3 months prior to study and at least 6 months off of OCs
Key exclusion criteria (7 listed)
- Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
- Current or recent remission of cancer
- Regular use of NSAID (except low-dose aspirin), anticoagulants
- Use of prescription drugs that would impact muscle protein synthesis (e.g., Statins, Lithium, ADHD medication, etc..)
- Insertion of intrauterine device (IUD) - exception: copper
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 |
|---|---|---|
| Habitual ActivityAlso: Free-Living ActivityParticipants will maintain habitual levels of physical activity (inclusive of structured physical activity). | Behavioural | At-Home Phase, In-Person Phase |
| Step-ReductionAlso: Reduced Physical ActivityParticipants will be required to reduce their daily step-counts to <2,000 steps/day. Further, they will be required to refrain from structured physical activity. | Behavioural | At-Home Phase |
| Resistance ExerciseAlso: Full-Body Resistance ExerciseParticipants will undergo a 50-minute resistance exercise protocol, which includes multiple sets of different exercises using weights. Each set will consist of 10 repetitions at 75% of their 1 repetition maximum (1RM). The exercises include bench press superset with lat pulldowns, overhead press superset with seated cable rows, leg press, and leg extensions with 90s rest in between sets. Before the exercise protocol, there will be a standardized 10-minute warm-up that involves cycling, leg swings, arm circles, bodyweight squats, and bench push-ups | Behavioural | In-Person Phase |
Primary outcome
Exogenous Leucine Oxidation (umol/kg)
Time frame: 5 hours
Exogenous Leucine Oxidation determined from breath 13CCO2 enrichment. Breath samples will be collected every 20-30min after test drink ingestion to determine breath 13CO2 enrichment. Total leucine oxidation will be determined from the area under the 13CO2 enrichment by time curve.
Net Leucine Retention (umol/kg)
Time frame: 5 hours
Whole-Body Net Leucine Retention determined from the difference between exogenous leucine oxidation and leucine ingestion the 6 hour measurement period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Ines Kortebi, MSc study director
University of Toronto
Hugo JW Fung, PhD (c) study chair
University of Toronto
Daniel R Moore, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual Activity, Step-Reduction and Resistance Exercise in people with Resistance Exercise and Physical Inactivity, run by University of Toronto 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 4 inclusion and 7 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 17 Jan 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 Daniel R Moore, PhD (4169464088, dr.moore@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exogenous Leucine Oxidation (umol/kg) (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2024.