Recruiting

Observational Study

Sponsor:

University of Toronto

Code:

NCT05422300

Conditions

Dietary Protein

Female Protein Metabolism

Anabolic Sensitivity

Resistance Exercise

Young Adult Females

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Fed

Ex-Fed

Study Details

Brief 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.

Conditions

Dietary Protein

Female Protein Metabolism

Anabolic Sensitivity

Resistance Exercise

Young Adult Females

Study ID

NCT05422300

Start date

Jun 20, 2022

Status verified date

Jul, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

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:

  • 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)

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Mid-Follicular Phase

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

experimental: Mid-Luteal Phase

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

Interventions

Fed

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.

Ex-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.

Primary outcome measure

  • Net-Leucine Retention (umol/kg) [ Time Frame: 6 hours ]
  • Exogenous Leucine Oxidation (umol/kg) [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Michael Mazzulla, PhD

m.mazzulla@mail.utoronto.ca

Locations

University of Toronto

Recruiting

Toronto, Ontario, Canada, M5S 2C9

Contacts

More Information

Sponsor

University of Toronto

Last update posted

Jul 13, 2023

Last verified

Jul, 2023

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2023-07-13.