Sedentary BehaviorARBTNCT05216809
Oral 'Breath Test' to Measure Anabolic Sensitivity in Young and Older Adults at Different Activity Levels
A study testing Habitual Physical Activity and Step-Reduction in people with Sedentary Behavior and Aging, run by University of Toronto at 1 site in Canada.
Trial summary
Recent work in the investigators laboratory has examined the ability of a non-invasive 13CO2 breath-test to assess differences in amino acid oxidation rates and net balance in young healthy males following protein feeding and resistance exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Aging, Sarcopenia
- What is being tested?
- Habitual Physical Activity and Step-Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to Mar 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy young (age: 18-35 years) or older (age: 60-80 years) adults
- Average daily step-count >7,000/day
- BMI between normal to overweight (18.5-29.9 kg/m2)
Who cannot join
- Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
- Use of anticoagulants
- Use of a walker, cane, or assistive walking device
- Current or recently remised cancer
- Infectious or gastrointestinal disease
- Inability to comply with study protocol (e.g., >2,000 steps/day during Step-Reduction Phase)
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- Regular tobacco use
- 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.
Matthew Lees, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9
Daniel R Moore, PhD, 416-946-4088, dr.moore@utoronto.ca
Hugo Fung, MSc, hugojernwai.fung@mail.utoronto.ca
About this study
Official title: The Efficacy of a Non-Invasive 13CO2 'Breath Test' to Detect Anabolic Resistance Following Step Reduction in Younger and Older Adults
Recent work in the investigators laboratory has examined the ability of a non-invasive 13CO2 breath-test to assess differences in amino acid oxidation rates and net balance in young healthy males following protein feeding and resistance exercise. The investigators aim to test the efficacy of this non-invasive 13CO2 breath-test to assess for differences in anabolic sensitivity between young and older adults following an acute period of habitual and reduced physical activity.
Read the detailed description
Aging is associated with a phenomenon known as anabolic resistance, whereby individuals are less responsive to anabolic stimuli (i.e., resistance exercise, dietary protein ingestion). Mild and severe reductions in physical activity are also known to play a key role in the emergence of anabolic resistance. Therefore, the purpose of this study is to investigate the ability of a non-invasive 13CO2 breath-test to assess differences in whole-body leucine oxidation and leucine net balance between younger and older individuals under conditions of habitual activity and following a period of reduced activity/step-reduction. In this manner, the ability of the methodology to distinguish anabolic sensitivity between young and older adult populations will be assessed.
Methods:
Total participant time commitment will span over 4 sessional dates:
Session 1 - Introduction Interested participants will be recruited to engage in a video conference call to undergo an introductory session. Participants will be provided with a comprehensive introduction to the study which will explain the research objectives, conduct, and associated risks. Participants will provide informed consent prior to the collection of any study information (i.e., anthropometrics and habitual activity levels). Eligibility will also be screened for at this time.
Session 2 - Body Composition Assessment Participants will consume a bolus of deuterium oxide (D2O) and provide saliva samples in order to estimate fat-free mass.
The remainder of the study will consist of seven consecutive days, wherein Phase 1 (Habitual Activity) will be subsequently followed by Phase 2 (Step-Reduction).
Phase 1 - Habitual Activity (Days 1-3) Participants will be asked to engage in their habitual activity pattern (> 7000 steps/day) while wearing an accelerometer and pedometer. Participants will be further instructed to maintain their normal dietary patterns and to track their diets over the course of these three days using diet logs.
Session 3 - Habitual Activity Metabolic Trial (Day 4) On the morning of the fourth day, following three days of habitual activity, participants will be subjected to the non-invasive 13CO2 breath-test to assess for whole-body leucine oxidation and net balance. This date will also serve as a lead-in to the subsequent Phase 2.
Phase 2 - Step-Reduction (Days 4-6) Participants will be asked to maintain their normal dietary patterns and track their dietary intake, but will need to adhere to a reduced daily step count (<2000 steps/day). Accelerometers and pedometers will be worn again during this period.
Session 4 - Step-Reduction Metabolic Trial (Day 7) On the morning of the 7th day, following three days of reduced daily step-count, participants will be subjected again to the non-invasive 13CO2 breath-test to assess for whole-body leucine oxidation and net balance. Ultimately, this will allow us to determine whether 3-days of reduced step-count will impart any changes on anabolic sensitivity.
For each metabolic trial, two urine samples (baseline and pooled enriched) will be collected, in addition to breath samples collected over a 6-hour post-prandial period at 20-30 minute intervals. These biological samples will be used to measure tracer excretion and oxidation, allowing us to determine rates of protein metabolism.
- Conditions
- Sedentary Behavior, Aging, Sarcopenia, Amino Acids, Dietary Protein
- Being tested
- Habitual Physical Activity, Step-Reduction
- Keywords
- Skeletal Muscle, Step-Reduction, Aging, Anabolic Resistance, Physical Activity, Stable Isotopes
- Medical subject headings
- Sedentary Behavior, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual Physical ActivityBehavioural
Also called Free-Living Activity
Participants will maintain habitual levels of physical activity (inclusive of structured physical activity). Participants will be required to maintain >7,000 steps/day.
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.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults | Active comparator | Equal sex distribution (10M/10F); ages 18-35 years old. Receives: Behavioral: Habitual Physical Activity; Behavioral: Step-Reduction |
| Older Adults | Active comparator | Equal sex distribution (6M/6F); ages 60-80 years old. Receives: Behavioral: Habitual Physical 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: 6 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: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Feb 2022
- Primary completion1 Jan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group Cohort Study Twenty healthy young (18-35 years of age; 10 females and 10 males) and twelve healthy older adults (60-80 years of age; 6 females and 6 males), for a total of 32 individuals, will undergo 3 days (Days 1-3) of Habitual Activity in a free-living setting (Phase 1) followed by a metabolic trial (Day 4), where individuals will be subjected to a non-invasive 13CO2 breath-test. This will also serve as a lead-in period for the subsequent 3 days of step-reduction (\<2,000 steps/day; Days 4-6). Following the 3-days of reduced daily step count (Day 7), participants will undergo another metabolic trial day involving the non-invasive 13CO2 breath-test in order for us to determine changes in anabolic sensitivity.
- Masking
- None (open label)
- Enrolment
- 32 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
- Daniel Moore, PhD, Principal investigator, University of TorontoHugo JW Fung, PhD (c), Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216809
- Sponsor's protocol ID
- ARBT
- Acronym
- ARBT
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2021
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Non-Invasive 13CO2 'Breath Test' to Detect Anabolic Resistance Following Step Reduction in Younger and Older Adults
- ClinicalTrials.gov ID
- NCT05216809
- Acronym / sponsor ID
- ARBT / ARBT
- Conditions
- Sedentary Behavior, Aging, Sarcopenia, Amino Acids, Dietary Protein
- Keywords
- Skeletal Muscle, Step-Reduction, Aging, Anabolic Resistance, Physical Activity, Stable Isotopes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Feb 2022 (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.
Recent work in the investigators laboratory has examined the ability of a non-invasive 13CO2 breath-test to assess differences in amino acid oxidation rates and net balance in young healthy males following protein feeding and resistance exercise. The investigators aim to test the efficacy of this non-invasive 13CO2 breath-test to assess for differences in anabolic sensitivity between young and older adults following an acute period of habitual and reduced physical activity.
Detailed description
Aging is associated with a phenomenon known as anabolic resistance, whereby individuals are less responsive to anabolic stimuli (i.e., resistance exercise, dietary protein ingestion). Mild and severe reductions in physical activity are also known to play a key role in the emergence of anabolic resistance. Therefore, the purpose of this study is to investigate the ability of a non-invasive 13CO2 breath-test to assess differences in whole-body leucine oxidation and leucine net balance between younger and older individuals under conditions of habitual activity and following a period of reduced activity/step-reduction. In this manner, the ability of the methodology to distinguish anabolic sensitivity between young and older adult populations will be assessed.
Methods:
Total participant time commitment will span over 4 sessional dates:
Session 1 - Introduction Interested participants will be recruited to engage in a video conference call to undergo an introductory session. Participants will be provided with a comprehensive introduction to the study which will explain the research objectives, conduct, and associated risks. Participants will provide informed consent prior to the collection of any study information (i.e., anthropometrics and habitual activity levels). Eligibility will also be screened for at this time.
Session 2 - Body Composition Assessment Participants will consume a bolus of deuterium oxide (D2O) and provide saliva samples in order to estimate fat-free mass.
The remainder of the study will consist of seven consecutive days, wherein Phase 1 (Habitual Activity) will be subsequently followed by Phase 2 (Step-Reduction).
Phase 1 - Habitual Activity (Days 1-3) Participants will be asked to engage in their habitual activity pattern (> 7000 steps/day) while wearing an accelerometer and pedometer. Participants will be further instructed to maintain their normal dietary patterns and to track their diets over the course of these three days using diet logs.
Session 3 - Habitual Activity Metabolic Trial (Day 4) On the morning of the fourth day, following three days of habitual activity, participants will be subjected to the non-invasive 13CO2 breath-test to assess for whole-body leucine oxidation and net balance. This date will also serve as a lead-in to the subsequent Phase 2.
Phase 2 - Step-Reduction (Days 4-6) Participants will be asked to maintain their normal dietary patterns and track their dietary intake, but will need to adhere to a reduced daily step count (<2000 steps/day). Accelerometers and pedometers will be worn again during this period.
Session 4 - Step-Reduction Metabolic Trial (Day 7) On the morning of the 7th day, following three days of reduced daily step-count, participants will be subjected again to the non-invasive 13CO2 breath-test to assess for whole-body leucine oxidation and net balance. Ultimately, this will allow us to determine whether 3-days of reduced step-count will impart any changes on anabolic sensitivity.
For each metabolic trial, two urine samples (baseline and pooled enriched) will be collected, in addition to breath samples collected over a 6-hour post-prandial period at 20-30 minute intervals. These biological samples will be used to measure tracer excretion and oxidation, allowing us to determine rates of protein metabolism.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Group Cohort Study Twenty healthy young (18-35 years of age; 10 females and 10 males) and twelve healthy older adults (60-80 years of age; 6 females and 6 males), for a total of 32 individuals, will undergo 3 days (Days 1-3) of Habitual Activity in a free-living setting (Phase 1) followed by a metabolic trial (Day 4), where individuals will be subjected to a non-invasive 13CO2 breath-test. This will also serve as a lead-in period for the subsequent 3 days of step-reduction (<2,000 steps/day; Days 4-6). Following the 3-days of reduced daily step count (Day 7), participants will undergo another metabolic trial day involving the non-invasive 13CO2 breath-test in order for us to determine changes in anabolic sensitivity.
| Arm | Type | Receives |
|---|---|---|
| Young Adults | Active comparator | Behavioral: Habitual Physical Activity, Behavioral: Step-ReductionEqual sex distribution (10M/10F); ages 18-35 years old. |
| Older Adults | Active comparator | Behavioral: Habitual Physical Activity, Behavioral: Step-ReductionEqual sex distribution (6M/6F); ages 60-80 years old. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy young (age: 18-35 years) or older (age: 60-80 years) adults
- Average daily step-count >7,000/day
- BMI between normal to overweight (18.5-29.9 kg/m2)
Key exclusion criteria (11 listed)
- Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
- Use of anticoagulants
- Use of a walker, cane, or assistive walking device
- Current or recently remised cancer
- Infectious or gastrointestinal disease
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 Physical ActivityAlso: Free-Living ActivityParticipants will maintain habitual levels of physical activity (inclusive of structured physical activity). Participants will be required to maintain >7,000 steps/day. | Behavioural | Older Adults, Young Adults |
| 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 | Older Adults, Young Adults |
Primary outcome
Exogenous Leucine Oxidation (umol/kg)
Time frame: 6 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: 6 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 9 Nov 2023.
- 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.
Matthew Lees, PhD contact
Daniel Moore, PhD principal investigator
University of Toronto
Hugo JW Fung, PhD (c) study director
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 Physical Activity and Step-Reduction in people with Sedentary Behavior 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 3 inclusion and 11 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 9 Nov 2023. 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: 6 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 9 Nov 2023.