Inactivity, PhysicalNFRFNCT06744491
Oral 'Breath Test' to Measure Anabolic Sensitivity to a Protein Meal Across the Age and Physical Activity Spectrum
An observational study of Inactivity, Physical and Aging, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan, between biological sexes, and with varying physical activity levels. Read more about this study
- Who is it for?
- Ages 8 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity, Physical, Aging, Healthy Aging
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Convenience sample of individuals who qualify for the corresponding cohorts based on inclusion/exclusion criteria stated.
Who may be able to join
- Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone)
- Chronological age for Healthy Young (age: 18-35 years) or Older (age: 60-80 years) adults
- Chronological age between 8 to 16 years, with maturity offset < -1 year from age of Peak Height Velocity (aPHV) for children and between -0.5 to +1.5 years from aPHV in adolescent participants
- BMI between normal to overweight (18.5 - 29.9 kg/m2)
Who cannot join
- Regular use of nonsteroidal anti-inflammatory dugs (with the exception of daily low-dose aspirin)
- use of anticoagulants
- use of a walker, cane, or assistive walking device
- infectious or gastrointestinal disease
- inability to comply with study protocol (e.g., unable to track diet)
- regular tobacco use
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- self-reported illicit drug use (e.g., growth hormone, testosterone, etc.)
- diagnosed chronic illness (e.g., type 2 diabetes, heart disease, thyroid disease)
- pregnant
- hormonal replacement therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hugo JW Fung, PhD Candidate contact
Canada1 site
Goldring Center for High Performance Sport
Toronto, Ontario, M5S 2C9
Hugo JW Fung, PhD Candidate, 416-946-5620, hugojernwai.fung@utoronto.ca
About this study
Official title: Anabolic Sensitivity Across the Lifespan
The purpose of this study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan, between biological sexes, and with varying physical activity levels.
Read the detailed description
Skeletal muscle is a dynamic tissue that responds to anabolic (i.e., growth) stimuli such as protein ingestion and exercise. Differences in age and physical activity levels will influence an individual's ability to respond to these anabolic stimuli; this concept is known as anabolic sensitivity. For instance, older and less physically active individuals will display lower anabolic sensitivity (i.e., anabolic resistance) to a bout of exercise or the consumption of protein in comparison to younger, more physically active individuals. Seeing that individuals with anabolic resistance are at a greater risk for losing muscle mass over time, it is important to understand the anabolic sensitivity/resistance of an individual to assess for the efficiency of growth across the health and lifespan, in addition to a potential screen for metabolic alterations that could manifest into changes in lean body and muscle mass.
Traditional methods to assess for skeletal muscle anabolism and protein metabolism requires in-person and invasive research methods (i.e., stable isotope infusions and muscle biopsies) in controlled laboratory or clinical settings. However, there are many risks associated with these invasive procedures and they are not always feasible in all populations (e.g., children, clinical populations, etc..). Our lab has recently developed a non-invasive 13C breath test which employs an oral stable isotope tracer. Our breath test allows us to assess for anabolic sensitivity in response to protein ingestion, by determining how much of the ingested protein was used to build (synthesize) new proteins in our body (i.e., anabolism) or used as a source of energy (through a process called oxidation). As such, the purpose of the present study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan and with varying physical activity levels.
- Conditions
- Inactivity, Physical, Aging, Healthy Aging, Growth & Development, Sex Differences, Anabolic Sensitivity
- Keywords
- anabolic sensitivity, aging, growth and development, physical activity, skeletal muscle, stable isotopes
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Children as defined by maturity offset via age from peak height velocity (aPHV < -1.0 years). | |
| Adolescent | Adolescents as defined by maturity offset via age from peak height velocity (aPHV -0.5 to +1.5 years) | |
| Young Adults | Young adults as defined by chronological age between ages 18 - 35 years | |
| Older Adults | Older adults as defined by chronological age between ages 60 - 80 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid oxidation and net protein balance
Amino acid oxidation and net protein balance assessed by oral 1-13C Leucine tracer. Net protein balance is derived from the difference between amino acid intake (known) and total amino acid oxidation over the 6h post-prandial measurement period.
Measured: 6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inactivity, PhysicalStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744491
- Sponsor's protocol ID
- 00044004
- Acronym
- NFRF
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Sensitivity Across the Lifespan
- ClinicalTrials.gov ID
- NCT06744491
- Acronym / sponsor ID
- NFRF / 00044004
- Conditions
- Inactivity, Physical, Aging, Healthy Aging, Growth & Development, Sex Differences, Anabolic Sensitivity
- Keywords
- anabolic sensitivity, aging, growth and development, physical activity, skeletal muscle, stable isotopes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 Dec 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.
The purpose of this study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan, between biological sexes, and with varying physical activity levels.
Detailed description
Skeletal muscle is a dynamic tissue that responds to anabolic (i.e., growth) stimuli such as protein ingestion and exercise. Differences in age and physical activity levels will influence an individual's ability to respond to these anabolic stimuli; this concept is known as anabolic sensitivity. For instance, older and less physically active individuals will display lower anabolic sensitivity (i.e., anabolic resistance) to a bout of exercise or the consumption of protein in comparison to younger, more physically active individuals. Seeing that individuals with anabolic resistance are at a greater risk for losing muscle mass over time, it is important to understand the anabolic sensitivity/resistance of an individual to assess for the efficiency of growth across the health and lifespan, in addition to a potential screen for metabolic alterations that could manifest into changes in lean body and muscle mass.
Traditional methods to assess for skeletal muscle anabolism and protein metabolism requires in-person and invasive research methods (i.e., stable isotope infusions and muscle biopsies) in controlled laboratory or clinical settings. However, there are many risks associated with these invasive procedures and they are not always feasible in all populations (e.g., children, clinical populations, etc..). Our lab has recently developed a non-invasive 13C breath test which employs an oral stable isotope tracer. Our breath test allows us to assess for anabolic sensitivity in response to protein ingestion, by determining how much of the ingested protein was used to build (synthesize) new proteins in our body (i.e., anabolism) or used as a source of energy (through a process called oxidation). As such, the purpose of the present study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan and with varying physical activity levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children as defined by maturity offset via age from peak height velocity (aPHV < -1.0 years). |
| Adolescent | – | –Adolescents as defined by maturity offset via age from peak height velocity (aPHV -0.5 to +1.5 years) |
| Young Adults | – | –Young adults as defined by chronological age between ages 18 - 35 years |
| Older Adults | – | –Older adults as defined by chronological age between ages 60 - 80 years |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Convenience sample of individuals who qualify for the corresponding cohorts based on inclusion/exclusion criteria stated.
Key inclusion criteria (4 listed)
- Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone)
- Chronological age for Healthy Young (age: 18-35 years) or Older (age: 60-80 years) adults
- Chronological age between 8 to 16 years, with maturity offset < -1 year from age of Peak Height Velocity (aPHV) for children and between -0.5 to +1.5 years from aPHV in adolescent participants
- BMI between normal to overweight (18.5 - 29.9 kg/m2)
Key exclusion criteria (10 listed)
- Regular use of nonsteroidal anti-inflammatory dugs (with the exception of daily low-dose aspirin)
- use of anticoagulants
- use of a walker, cane, or assistive walking device
- infectious or gastrointestinal disease
- inability to comply with study protocol (e.g., unable to track diet)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amino acid oxidation and net protein balance
Time frame: 6 Hours
Amino acid oxidation and net protein balance assessed by oral 1-13C Leucine tracer. Net protein balance is derived from the difference between amino acid intake (known) and total amino acid oxidation over the 6h post-prandial measurement period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hugo JW Fung, PhD Candidate contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inactivity, Physical and Aging, 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 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: opening soon, as of the sponsor's last update on 20 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Amino acid oxidation and net protein balance (time frame: 6 Hours). 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 20 Dec 2024.