Dietary ProteinFBTNCT05422300
A 'Non-Invasive' Breath Test to Determine Anabolic Sensitivity in Females
A study testing Fed and Ex-Fed in people with Dietary Protein and Female Protein Metabolism, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Protein, Female Protein Metabolism, Anabolic Sensitivity
- What is being tested?
- Fed and Ex-Fed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2022to 31 Dec 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Michael Mazzulla, PhD contact
Canada1 site, 1 recruiting
- Recruiting
University of Toronto
Toronto, Ontario, M5S 2C9
Daniel R Moore, PhD, 416-946-4088, dr.moore@utoronto.ca
Nicki Pourhashemi, MSc Student
About this study
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.
- Conditions
- Dietary Protein, Female Protein Metabolism, Anabolic Sensitivity, Resistance Exercise, Young Adult Females
- Being tested
- Fed, Ex-Fed
- 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
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FedBehavioural
Also called Feeding at Rest
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-FedBehavioural
Also called Exercise with Feeding
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.
| Study group | Role | What they receive |
|---|---|---|
| Mid-Follicular Phase | Experimental | 7-10 days after the onset of menses, determined by self-reports and confirmed with ovulation test kits. Receives: Behavioral: Fed; Behavioral: Ex-Fed |
| Mid-Luteal Phase | Experimental | 5-7 days after ovulation, determined by self-reports and confirmed with ovulation test kits. Receives: Behavioral: Fed; Behavioral: Ex-Fed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start20 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ProteinStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a 2-way counterbalanced crossover design. A total 10 young women (Ages: 18-35 years old) will be recruited and randomized into either the mid- follicular (7-10 days after the onset of menses) or mid-luteal phase (5-7 days after ovulation) (n=5, respectively). Participants will take part in two metabolic trials: Fed trial at rest (FED) and fed trial with resistance exercise (EX-FED). Following a minimum 3-day washout period, participants will complete the other trial, where both trials will be completed within the same phase of the menstrual cycle, depending on which group they were randomized into. Participants will be asked to self-report their menstrual cycle status, albeit ovulation test kits will be used to verify the cycle phase prior to each metabolic trial.
- Masking
- None (open label)
- Enrolment
- 10 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
- Nicki Pourhashemi, MSc Student, Study director, Faculty of Kinesiology and Physical EducationHugo JW Fung, PhD (c), Study director, Faculty of Kinesiology and Physical EducationJonathan Aguilera, PhD Student, Study director, Faculty of Kinesiology and Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422300
- Sponsor's protocol ID
- FBT
- Acronym
- FBT
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2022
- Last updated
- 13 Jul 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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 'Non-Invasive' Breath Test to Determine Anabolic Sensitivity in Females
- ClinicalTrials.gov ID
- NCT05422300
- Acronym / sponsor ID
- FBT / FBT
- Conditions
- Dietary Protein, Female Protein Metabolism, Anabolic Sensitivity, Resistance Exercise, Young Adult Females
- Keywords
- Dietary Proteins/Administration & Dosage, Skeletal Muscle Metabolism, Human Adult Females, Diet, Exercise; Resistance Exercise, Amino Acids, Muscle Protein Synthesis, Skeletal Muscle Anabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Jun 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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a 2-way counterbalanced crossover design. A total 10 young women (Ages: 18-35 years old) will be recruited and randomized into either the mid- follicular (7-10 days after the onset of menses) or mid-luteal phase (5-7 days after ovulation) (n=5, respectively). Participants will take part in two metabolic trials: Fed trial at rest (FED) and fed trial with resistance exercise (EX-FED). Following a minimum 3-day washout period, participants will complete the other trial, where both trials will be completed within the same phase of the menstrual cycle, depending on which group they were randomized into. Participants will be asked to self-report their menstrual cycle status, albeit ovulation test kits will be used to verify the cycle phase prior to each metabolic trial.
| Arm | Type | Receives |
|---|---|---|
| Mid-Follicular Phase | Experimental | Behavioral: Fed, Behavioral: Ex-Fed7-10 days after the onset of menses, determined by self-reports and confirmed with ovulation test kits. |
| Mid-Luteal Phase | Experimental | Behavioral: Fed, Behavioral: Ex-Fed5-7 days after ovulation, determined by self-reports and confirmed with ovulation test kits. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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...)
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 |
|---|---|---|
| FedAlso: Feeding at RestSubjects 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. | Behavioural | Mid-Follicular Phase, Mid-Luteal Phase |
| Ex-FedAlso: Exercise with FeedingParticipants 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. | Behavioural | Mid-Follicular Phase, Mid-Luteal Phase |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
Michael Mazzulla, PhD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fed and Ex-Fed in people with Dietary Protein and Female Protein Metabolism, 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 5 inclusion and 8 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 13 Jul 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?
Net-Leucine Retention (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 13 Jul 2023.