Healthy Adult MalesNCT04887727
Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans
A study testing Crystalline amino acids to assess myofibrillar protein synthesis rates and Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance in people with Healthy Adult Males, run by University of Toronto at 1 site in Canada.
Trial summary
Previous studies have used a combination of oral L-[1-13C]leucine and intravenous labeled L-[5,5,5-2H3]leucine to assess the acute postprandial changes in whole-body protein turnover (12, 19). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Males
- What is being tested?
- Crystalline amino acids to assess myofibrillar protein synthesis rates and Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2019to 31 Aug 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Currently performing structured physical activity 2-5 days per week
Who cannot join
- Unable to safely perform exercise as per PARQ+ guidelines
- Currently using tobacco products
- Currently using or have history of anabolic steroid use
- Diagnosed with medical condition including type 2 diabetes, cancer, heart disease
- Unable to abstain from supplement use (HMB, branched chain amino acids, phosphatidic acid) for at least three weeks prior to trial
- currently using medications known to affect protein metabolism e.g. corticosteroids, NSAID, prescription-strength acne medication
- allergic to local anesthetics
- female: Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence indices of the post-exercise myofibrillar protein synthetic response. Accordingly, the study will include males to ensure a stable hormonal environment and to increase the homogeneity of the physiological response.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9
About this study
Previous studies have used a combination of oral L-[1-13C]leucine and intravenous labeled L-[5,5,5-2H3]leucine to assess the acute postprandial changes in whole-body protein turnover (12, 19). Intravenous and dietary-labeled amino acid tracers have also been used in tandem to assess rates of myofibrillar protein synthesis in response to bolus protein ingestion and resistance exercise (46). By validating whole-body net balance to myofibrillar protein synthesis, our proposed multi-tracer approach will develop minimally invasive models to study protein turnover in a variety of populations in which traditional infusions and/or repeated blood samples are not possible (i.e. pediatric, free-living populations).
Read the detailed description
The primary objective of the proposed study is to validate the use of a novel oral tracer model to accurately and reliably measure myofibrillar protein synthesis. It is hypothesized that oral L-[1-13C]leucine and L-[ring-2H5]phenylalanine, ingested as a bolus to mimic an intravenous 'pulse dose' administration (51, 65), will reveal similar rates of myofibrillar protein synthesis when compared to traditional intravenous L-[5,5,5-2H3]leucine infusion. Moreover, it is hypothesized that both methods will reveal the expected graded changes in myofibrillar protein synthesis in response to feeding and resistance exercise (i.e. fasted<feeding<exercise \& feeding).
The secondary objective of the proposed study is to develop and validate non-invasive models to measure whole-body amino acid oxidation and net balance in response to feeding and resistance exercise. It is hypothesized that whole-body net balance, as determined by a novel oral tracer model (i.e. L-[1-13C]leucine) , will align with traditional intravenous tracer methodology (i.e. L-[5,5,5-2H3]leucine) and reveal the expected physiological changes in whole-body protein turnover in response to feeding and resistance exercise (i.e. fasted<feeding<exercise \& feeding).
- Conditions
- Healthy Adult Males
- Being tested
- Crystalline amino acids to assess myofibrillar protein synthesis rates, Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalline amino acids to assess myofibrillar protein synthesis ratesDietary supplement
Amino acid dose = 0.25g/kg bodyweight
Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balanceDietary supplement
Amino acid dose = 0.25g/kg bodyweight
| Study group | Role | What they receive |
|---|---|---|
| Healthy, recreationally-active adult males - Muscle Trial | Experimental | Subjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-[1-13C]leucine and L-ring-[2H5]phenylalanine with a primed-constant infusion of L-[555-2H3]leucine to assess myofibrillar protein synthesis rates Receives: Dietary Supplement: Crystalline amino acids to assess myofibrillar protein synthesis rates |
| Healthy, recreationally-active adult males - Whole Body Trial | Experimental | Subjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-[1-13C]leucine with a primed-constant infusion of L-[555-2H3]leucine to whole-body protein turnover, amino acid oxidation, and net protein balance Receives: Dietary Supplement: Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar protein synthesis rates
Myofibrillar protein synthesis rates assessed by oral and intravenous tracers during Fast, Fed, and Ex-Fed
Measured: 5 hours
Secondary outcomes (4)
Whole-body protein turnover
Whole-body protein turnover assessed by oral and intravenous tracers during Fast, Fed, and Ex-Fed
Measured: 5 hours
Amino acid oxidation and net protein balance
Amino acid oxidation and net protein balance assessed by oral tracers during Fast, Fed, and Ex-Fed. Net protein balance is derived from the difference between amino acid intake (known) and total amino acid oxidation over the 5h measurement period.
Measured: 5 hours
Muscle anabolic signalling
Immunoblotting for mTORC1/key downstream targets of mTORC1
Measured: 2 and 5 hours
Amino acid transporter expression
Immunoblotting for amino acid transporters LAT1/SNAT2
Measured: 2 and 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start25 Feb 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult MalesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups: Fast, Fed, Ex-Fed Two trials per group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel R Moore, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887727
- Sponsor's protocol ID
- Connaught
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazzulla M, Hodson N, West DWD, Kumbhare DA, Moore DR. A non-invasive 13CO2 breath test detects differences in anabolic sensitivity with feeding and heavy resistance exercise in healthy young males: a randomized control trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):860-870. doi: 10.1139/apnm-2021-0808. Epub 2022 May 24.
PubMed 35609328
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans
- ClinicalTrials.gov ID
- NCT04887727
- Acronym / sponsor ID
- Connaught
- Conditions
- Healthy Adult Males
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 14 May 2021 (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.
Previous studies have used a combination of oral L-[1-13C]leucine and intravenous labeled L-[5,5,5-2H3]leucine to assess the acute postprandial changes in whole-body protein turnover (12, 19). Intravenous and dietary-labeled amino acid tracers have also been used in tandem to assess rates of myofibrillar protein synthesis in response to bolus protein ingestion and resistance exercise (46). By validating whole-body net balance to myofibrillar protein synthesis, our proposed multi-tracer approach will develop minimally invasive models to study protein turnover in a variety of populations in which traditional infusions and/or repeated blood samples are not possible (i.e. pediatric, free-living populations).
Detailed description
The primary objective of the proposed study is to validate the use of a novel oral tracer model to accurately and reliably measure myofibrillar protein synthesis. It is hypothesized that oral L-[1-13C]leucine and L-[ring-2H5]phenylalanine, ingested as a bolus to mimic an intravenous 'pulse dose' administration (51, 65), will reveal similar rates of myofibrillar protein synthesis when compared to traditional intravenous L-[5,5,5-2H3]leucine infusion. Moreover, it is hypothesized that both methods will reveal the expected graded changes in myofibrillar protein synthesis in response to feeding and resistance exercise (i.e. fasted<feeding<exercise \& feeding).
The secondary objective of the proposed study is to develop and validate non-invasive models to measure whole-body amino acid oxidation and net balance in response to feeding and resistance exercise. It is hypothesized that whole-body net balance, as determined by a novel oral tracer model (i.e. L-[1-13C]leucine) , will align with traditional intravenous tracer methodology (i.e. L-[5,5,5-2H3]leucine) and reveal the expected physiological changes in whole-body protein turnover in response to feeding and resistance exercise (i.e. fasted<feeding<exercise \& feeding).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three groups: Fast, Fed, Ex-Fed Two trials per group
| Arm | Type | Receives |
|---|---|---|
| Healthy, recreationally-active adult males - Muscle Trial | Experimental | Dietary Supplement: Crystalline amino acids to assess myofibrillar protein synthesis ratesSubjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-[1-13C]leucine and L-ring-[2H5]phenylalanine with a primed-constant infusion of L-[555-2H3]leucine to assess myofibrillar protein synthesis rates |
| Healthy, recreationally-active adult males - Whole Body Trial | Experimental | Dietary Supplement: Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balanceSubjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-[1-13C]leucine with a primed-constant infusion of L-[555-2H3]leucine to whole-body protein turnover, amino acid oxidation, and net protein balance |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male
- Currently performing structured physical activity 2-5 days per week
Key exclusion criteria (8 listed)
- Unable to safely perform exercise as per PARQ+ guidelines
- Currently using tobacco products
- Currently using or have history of anabolic steroid use
- Diagnosed with medical condition including type 2 diabetes, cancer, heart disease
- Unable to abstain from supplement use (HMB, branched chain amino acids, phosphatidic acid) for at least three weeks prior to trial
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 |
|---|---|---|
| Crystalline amino acids to assess myofibrillar protein synthesis ratesAmino acid dose = 0.25g/kg bodyweight | Dietary supplement | Healthy, recreationally-active adult males - Muscle Trial |
| Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balanceAmino acid dose = 0.25g/kg bodyweight | Dietary supplement | Healthy, recreationally-active adult males - Whole Body Trial |
Primary outcome
Myofibrillar protein synthesis rates
Time frame: 5 hours
Myofibrillar protein synthesis rates assessed by oral and intravenous tracers during Fast, Fed, and Ex-Fed
4 secondary outcomes
Whole-body protein turnover
Time frame: 5 hours
Amino acid oxidation and net protein balance
Time frame: 5 hours
Muscle anabolic signalling
Time frame: 2 and 5 hours
Amino acid transporter expression
Time frame: 2 and 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 35609328Mazzulla M, Hodson N, West DWD, Kumbhare DA, Moore DR. A non-invasive 13CO2 breath test detects differences in anabolic sensitivity with feeding and heavy resistance exercise in healthy young males: a randomized control trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):860-870. doi: 10.1139/apnm-2021-0808. Epub 2022 May 24.
- 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.
Daniel R Moore, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalline amino acids to assess myofibrillar protein synthesis rates and Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance in people with Healthy Adult Males, 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 2 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: finished, as of the sponsor's last update on 14 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofibrillar protein synthesis rates (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887727, which also lists 1 linked publication.
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 14 May 2021.