- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744491
Oral 'Breath Test' to Measure Anabolic Sensitivity to a Protein Meal Across the Age and Physical Activity Spectrum (NFRF)
Anabolic Sensitivity Across the Lifespan
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Daniel R Moore, PhD
- Phone Number: 4169464088
- Email: dr.moore@utoronto.ca
Study Contact Backup
- Name: Hugo JW Fung, PhD Candidate
- Email: hugojernwai.fung@utoronto.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2C9
- Goldring Center for High Performance Sport
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Contact:
- Hugo JW Fung, PhD Candidate
- Phone Number: 416-946-5620
- Email: hugojernwai.fung@utoronto.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children
Children as defined by maturity offset via age from peak height velocity (aPHV < -1.0 years).
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Adolescent
Adolescents as defined by maturity offset via age from peak height velocity (aPHV -0.5 to +1.5 years)
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Young Adults
Young adults as defined by chronological age between ages 18 - 35 years
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Older Adults
Older adults as defined by chronological age between ages 60 - 80 years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Amino acid oxidation and net protein balance
Time Frame: 6 Hours
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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.
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6 Hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00044004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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