InterventionalDiExNCT05754125
In Vivo and in Vitro Anabolic Potential of Essential Amino Acids Following Resistance Exercise
A study testing Di-Leucine Supplement, BCAA Supplement and Collagen Supplement in people with Interventional, run by University of Toronto at 1 site in Canada.
Trial summary
This study seeks to investigate the anabolic potential of a dileucine-enriched essential amino acid (EAA) formulation compared with a branched chain amino acid (BCAA) alternative and a collagen beverage on muscle protein anabolism and catabolism following a bout of resistance exercise training. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Interventional
- What is being tested?
- Di-Leucine Supplement, BCAA Supplement and Collagen Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2023to 30 Jan 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Trained individuals currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months
Who cannot join
- Inability to perform physical activity as determined by the PAR-Q
- Inability to adhere to protocol guidelines (e.g., alcohol, 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
Show all 12Show fewer
- Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
- Participants that are amenorrheic (females only)
- On medications that may interfere with protein metabolism (e.g. anti-inflammatory drugs, hormone therapy)
- Regular tobacco use (e.g. daily use of oral or inhaled tobacco)
- Illicit drug use (e.g. growth hormone, testosterone, etc.)
- Inability to comply with the study protocol as judged by the investigators
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
This study seeks to investigate the anabolic potential of a dileucine-enriched essential amino acid (EAA) formulation compared with a branched chain amino acid (BCAA) alternative and a collagen beverage on muscle protein anabolism and catabolism following a bout of resistance exercise training. To do this, investigators will employ a novel 'breath test' method developed in our laboratory as well as blood and urine sampling. The results of this study will allow us to better understand the anabolic potential of dileucine which could have implications for people engaging in regular resistance training (such as athletes) as well as people that need to preserve muscle mass (older people who are susceptible to anabolic resistance and sarcopenia, or muscle wasting).
- Conditions
- Interventional
- Being tested
- Di-Leucine Supplement, BCAA Supplement, Collagen Supplement
- Keywords
- Di-leucine, Branched chain amino acids, Collagen, Amino acids, anabolism, catabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Di-Leucine SupplementDietary supplement
Participants will consume a amino acid supplement containing Di-Leucine following resistance exercise and their whole body anabolism will be determined over the subsequent 6 hours
BCAA SupplementDietary supplement
Participants will consume a amino acid supplement containing branched chain amino acids (BCAA) following resistance exercise and their whole body anabolism will be determined over the subsequent hours
Collagen SupplementDietary supplement
Participants will consume a amino acid supplement containing Collagen protein following resistance exercise and their whole body anabolism will be determined over the subsequent hours
| Study group | Role | What they receive |
|---|---|---|
| Di-Leucine supplement | Experimental | Participants will consume a amino acid supplement containing Di-Leucine following resistance exercise and their whole body anabolism will be determined over the subsequent 6 hours Receives: Dietary Supplement: Di-Leucine Supplement |
| BCAA Supplement | Experimental | Participants will consume a amino acid supplement containing branched chain amino acids (BCAA) following resistance exercise and their whole body anabolism will be determined over the subsequent hours Receives: Dietary Supplement: BCAA Supplement |
| Collagen Supplement | Experimental | Participants will consume a amino acid supplement containing collagen protein following resistance exercise and their whole body anabolism will be determined over the subsequent hours Receives: Dietary Supplement: Collagen Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-Body Protein Synthesis
Investigators will measure the enrichment of [13CO2] in the breath by isotope ratio mass spectrometry (IRMS) in atom percent excess (APE). The measurement of carbon dioxide production (VCO2) and stable isotope tracer enrichment in the breath allows for the assessment of the rate at which amino acids are used for energy (i.e., oxidized), rather than for protein synthesis (i.e., retained in the body) by calculating the fraction of expired CO2 that contains 13C. Leucine retention (umol/kg) will then be calculated from the difference between the known amount of leucine provided (ingested) and leucine oxidation (as determined from 13CO2 breath enrichment).
Measured: 6 hours
Secondary outcomes (4)
Urinary Measures (Muscle Protein Breakdown)
Investigators will measure urinary 3-methylhistidine (3MH) as an indirect marker of muscle protein breakdown over the course of the trial (6 hours) through pooled urine collection vs baseline urine.
Measured: 6 hours
Murine Cell-Based Experiments (ex-vivo experiments) -hypertrophy
Investigators will use human serum obtained from fasted and fed timepoints (15, 30, 45 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell growth, myotube diameter (hypertrophy) will be measured via microscopy following short term (4 hours) and long-term (24 hour) incubation in the human conditioned culture media.
Measured: 60 minutes
Murine Cell-Based Experiments (ex-vivo experiments) - Protein Synthesis
Investigators will use human serum obtained from fasted and fed timepoints (15, 30, 45 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell protein synthesis, puromycin incorporation (measure of protein synthesis) will be measured via western blot.
Measured: 60 minutes
Murine Cell-Based Experiments (ex-vivo experiments) - mTORC1 Signalling
Investigators will use human serum obtained from fasted and fed timepoints (15, 30, 45 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell anabolic signalling mTORC1 signalling will be measured via western blot.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start21 Jan 2023
- Primary completion30 Jul 2023
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionalStudies 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
- Crossover
- Model description
- Cross over study design; Block randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754125
- Sponsor's protocol ID
- DiEx
- Acronym
- DiEx
- Status last verified
- Nov 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo and in Vitro Anabolic Potential of Essential Amino Acids Following Resistance Exercise
- ClinicalTrials.gov ID
- NCT05754125
- Acronym / sponsor ID
- DiEx / DiEx
- Conditions
- Interventional
- Keywords
- Di-leucine, Branched chain amino acids, Collagen, Amino acids, anabolism, catabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 3 Mar 2023 (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.
This study seeks to investigate the anabolic potential of a dileucine-enriched essential amino acid (EAA) formulation compared with a branched chain amino acid (BCAA) alternative and a collagen beverage on muscle protein anabolism and catabolism following a bout of resistance exercise training. To do this, investigators will employ a novel 'breath test' method developed in our laboratory as well as blood and urine sampling. The results of this study will allow us to better understand the anabolic potential of dileucine which could have implications for people engaging in regular resistance training (such as athletes) as well as people that need to preserve muscle mass (older people who are susceptible to anabolic resistance and sarcopenia, or muscle wasting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Cross over study design; Block randomized.
| Arm | Type | Receives |
|---|---|---|
| Di-Leucine supplement | Experimental | Dietary Supplement: Di-Leucine SupplementParticipants will consume a amino acid supplement containing Di-Leucine following resistance exercise and their whole body anabolism will be determined over the subsequent 6 hours |
| BCAA Supplement | Experimental | Dietary Supplement: BCAA SupplementParticipants will consume a amino acid supplement containing branched chain amino acids (BCAA) following resistance exercise and their whole body anabolism will be determined over the subsequent hours |
| Collagen Supplement | Experimental | Dietary Supplement: Collagen SupplementParticipants will consume a amino acid supplement containing collagen protein following resistance exercise and their whole body anabolism will be determined over the subsequent hours |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Trained individuals currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months
Key exclusion criteria (12 listed)
- Inability to perform physical activity as determined by the PAR-Q
- Inability to adhere to protocol guidelines (e.g., alcohol, 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)
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 |
|---|---|---|
| Di-Leucine SupplementParticipants will consume a amino acid supplement containing Di-Leucine following resistance exercise and their whole body anabolism will be determined over the subsequent 6 hours | Dietary supplement | Di-Leucine supplement |
| BCAA SupplementParticipants will consume a amino acid supplement containing branched chain amino acids (BCAA) following resistance exercise and their whole body anabolism will be determined over the subsequent hours | Dietary supplement | BCAA Supplement |
| Collagen SupplementParticipants will consume a amino acid supplement containing Collagen protein following resistance exercise and their whole body anabolism will be determined over the subsequent hours | Dietary supplement | Collagen Supplement |
Primary outcome
Whole-Body Protein Synthesis
Time frame: 6 hours
Investigators will measure the enrichment of [13CO2] in the breath by isotope ratio mass spectrometry (IRMS) in atom percent excess (APE). The measurement of carbon dioxide production (VCO2) and stable isotope tracer enrichment in the breath allows for the assessment of the rate at which amino acids are used for energy (i.e., oxidized), rather than for protein synthesis (i.e., retained in the body) by calculating the fraction of expired CO2 that contains 13C. Leucine retention (umol/kg) will then be calculated from the difference between the known amount of leucine provided (ingested) and leucine oxidation (as determined from 13CO2 breath enrichment).
4 secondary outcomes
Urinary Measures (Muscle Protein Breakdown)
Time frame: 6 hours
Murine Cell-Based Experiments (ex-vivo experiments) -hypertrophy
Time frame: 60 minutes
Murine Cell-Based Experiments (ex-vivo experiments) - Protein Synthesis
Time frame: 60 minutes
Murine Cell-Based Experiments (ex-vivo experiments) - mTORC1 Signalling
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Di-Leucine Supplement, BCAA Supplement and Collagen Supplement in people with Interventional, 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 1 inclusion and 12 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 9 Nov 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?
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?
Whole-Body Protein Synthesis (time frame: 6 hours). 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 9 Nov 2023.