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RecruitingNCT05422300FBTUpdated Jul 13, 2023

A 'Non-Invasive' Breath Test to Determine Anabolic Sensitivity in Females

An interventional study of Fed and Ex-Fed in Dietary Protein, Female Protein Metabolism and Anabolic Sensitivity, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by University of Toronto · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

The maintenance of lean body mass, especially skeletal muscle, is vital for optimal health and performance across the lifespan. The protein component of lean body mass is in a constant state of turnover, involving the simultaneous breakdown of old and/or damaged proteins and the synthesis of new proteins. These processes collectively determine if someone gains or loses lean body mass. Eating a protein-rich meal or performing resistance exercise can stimulate protein synthesis to gain lean body mass. Stable isotope "tracers" are amino acid building blocks that are slightly heavier than those naturally found in the body. In research, these are often used to assess changes in protein turnover in response to feeding and/or exercise. However, traditional stable isotope tracer methods involve the intravenous delivery of a tracer with blood sampling and muscle biopsies, which may be cumbersome or unfeasible for some for participants.

The investigators have recently developed and validated a non-invasive 'breath test' in males that measures the efficiency of the body for using amino acids in food to build new body proteins. The principle of this method is that leucine, an essential amino acid that the body must acquire from normal diet, can be used to build new body proteins or as a source of energy (i.e., oxidized). Since leucine is preferentially used in skeletal muscle, skeletal muscle protein metabolism can be non-invasively inferred . Any leucine "tracer" that is oxidized can be detected and measured in the carbon dioxide exhaled. It has been observed that less dietary leucine is oxidized when active males perform a bout of resistance exercise, meaning more was used to build muscle proteins. When performed habitually, resistance exercise can help skeletal muscles grow, compared to a rested-state, resulting in greater leucine retention in the body to build new proteins. Therefore, the purpose of this study is to validate this non-invasive breath test in females to increase the validity of the method in a wider range of populations. Ultimately, the results will further validate this non-invasive tool that can potentially detect whether different populations are sensitive to dietary amino acids and in a position to gain or lose lean body mass.

Read the detailed description

The objective of the present study is to validate the use of an oral L-[13C]-leucine stable isotope tracer, preferentially metabolized within skeletal muscle, to detect an exercise-induced increase in anabolic sensitivity (i.e., reduction in oxidation) in females. It is hypothesized that since resistance exercise enhances skeletal muscle protein synthesis, anabolic sensitivity measured through leucine retention would be greater with feeding after resistance exercise compared to feeding at rest.

02

Conditions studied

  • Dietary Protein
  • Female Protein Metabolism
  • Anabolic Sensitivity
  • Resistance Exercise
  • Young Adult Females

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Keywords

  • Dietary Proteins/Administration & Dosage
  • Skeletal Muscle Metabolism
  • Human Adult Females
  • Diet
  • Exercise; Resistance Exercise
  • Amino Acids
  • Muscle Protein Synthesis
  • Skeletal Muscle Anabolism
  • Stable Isotopes
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 10 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female sex
  • 18-35 years of age
  • BMI ≥18.5 kg/m2 and ≤ 30 kg/m2
  • Eumenorrheic (self-reported menstruation for prior 3 consecutive months)
  • Recreationally active; currently performing structured exercise (e.g. running, weightlifting, team-sport activity) at least once per week for ≥ 6 months before enrolment

Exclusion criteria

Exclusion Criteria:

  • Use of oral contraceptives
  • Inability to perform physical activity as determined by the PAR-Q+
  • Inability to adhere to protocol guidelines (e.g. alcohol, caffeine, habitual diet)
  • Regular tobacco use
  • Illicit drug use (e.g. growth hormone, testosterone, etc...)
  • Diagnosed medical condition under the care of a physician (e.g. type 2 diabetes)
  • Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc...) at least three weeks before the trial
  • Individuals on any medications known to affect protein metabolism (e.g. corticosteroids, non-steroidal anti-inflammatories, and/or prescription-strength acne medications)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Mid-Follicular Phase

    7-10 days after the onset of menses, determined by self-reports and confirmed with ovulation test kits.

    Behavioral: Fed · Behavioral: Ex-Fed

  • Experimental
    Mid-Luteal Phase

    5-7 days after ovulation, determined by self-reports and confirmed with ovulation test kits.

    Behavioral: Fed · Behavioral: Ex-Fed

Interventions

  • BehavioralFed

    Subjects will be fed a mixed-macronutrient beverage at rest (0.75g/kg lean body mass of carbohydrates; 0.25g/kg lean body mass of protein). Amino acid composition of the protein will be modelled off the composition of egg. Leucine content will be enriched to 5% with \[13C\]-leucine.

    Also known as: Feeding at Rest

  • BehavioralEx-Fed

    Participants will be subjected to a full-body resistance exercise protocol, consisting of an upper and lower body circuit. The upper body circuit will be a chest press and dumbbell row superset, whereas the lower body circuit will be leg press and leg extension (4 sets of 10 repetitions @ 75% of their 1 repetition max, respectively). The inter-set rest period will be 90 seconds. Subjects will be fed a mixed-macronutrient beverage at rest (0.75g/kg lean body mass of carbohydrates; 0.25g/kg lean body mass of protein). Amino acid composition of the protein will be modelled off the composition of egg. Leucine content will be enriched to 5% with \[13C\]-leucine.

    Also known as: Exercise with Feeding

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 hours

  2. 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.

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
  • University of Toronto
    Toronto, Ontario M5S 2C9, Canada
    • Daniel R Moore, PhD · Contact · dr.moore@utoronto.ca · 416-946-4088
    • Nicki Pourhashemi, MSc Student · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05422300
Lead sponsor
University of Toronto
Responsible party
Daniel Moore (Associate Professor, University of Toronto) — Principal investigator
First posted
Jun 16, 2022
Start date
Jun 20, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jul 13, 2023

Study contacts

Daniel R Moore, PhD
Contact
dr.moore@utoronto.ca
4169464088
Michael Mazzulla, PhD
Contact
m.mazzulla@mail.utoronto.ca
Nicki Pourhashemi, MSc Student
study director · Faculty of Kinesiology and Physical Education
Hugo JW Fung, PhD (c)
study director · Faculty of Kinesiology and Physical Education
Jonathan Aguilera, PhD Student
study director · Faculty of Kinesiology and Physical Education

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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