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Clinical Trial NCT06744491 (NFRF) for Inactivity, Physical, Aging, Healthy Aging, Growth & Development, Sex Differences, Anabolic Sensitivity, Protein Metabolism, Physical Activity is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Oral 'Breath Test' to Measure Anabolic Sensitivity to a Protein Meal Across the Age and Physical Activity Spectrum (NFRF)

Not yet recruiting
Clinical Trial NCT06744491 (NFRF) is an observational study for Inactivity, Physical, Aging, Healthy Aging, Growth & Development, Sex Differences, Anabolic Sensitivity, Protein Metabolism, Physical Activity is not yet recruiting. Enrollment is planned to begin on December 20, 2024 until the trial accrues 80 participants. Led by University of Toronto, this trial is expected to complete by August 31, 2025. The latest data from ClinicalTrials.gov was last updated on December 20, 2024.
Brief 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.
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.

Official Title

Anabolic Sensitivity Across the Lifespan

Conditions
Inactivity, PhysicalAgingHealthy AgingGrowth & DevelopmentSex DifferencesAnabolic SensitivityProtein MetabolismPhysical Activity
Other Study IDs
  • NFRF
  • 00044004
NCT ID Number
Start Date (Actual)
2024-12-20
Last Update Posted
2024-12-20
Completion Date (Estimated)
2025-08-31
Enrollment (Estimated)
80
Study Type
Observational
Status
Not yet recruiting
Keywords
anabolic sensitivity
aging
growth and development
physical activity
skeletal muscle
stable isotopes
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Children
Children as defined by maturity offset via age from peak height velocity (aPHV \< -1.0 years).
N/A
Adolescent
Adolescents as defined by maturity offset via age from peak height velocity (aPHV -0.5 to +1.5 years)
N/A
Young Adults
Young adults as defined by chronological age between ages 18 - 35 years
N/A
Older Adults
Older adults as defined by chronological age between ages 60 - 80 years
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
6 Hours
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
8 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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)

  • 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
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Study Responsible Party
Daniel Moore, Principal Investigator, Professor, Muscle Physiology, University of Toronto
Study Central Contact
Contact: Daniel R Moore, PhD, 4169464088, [email protected]
Contact: Hugo JW Fung, PhD Candidate, [email protected]
1 Study Locations in 1 Countries

Ontario

Goldring Center for High Performance Sport, Toronto, Ontario, M5S 2C9, Canada
Hugo JW Fung, PhD Candidate, Contact, 416-946-5620, [email protected]