InterventionalNCT05554653
Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis
A study testing Leucine enriched amino acids in people with Interventional, run by Daniel Moore at 1 site in Canada.
Trial summary
The primary objective will be to determine the effect of leucine-enriched essential amino acids (LEAA) compared to carbohydrate placebo on dietary incorporation of [D5] Phenylalanine \& [D5] Glycine into the three skeletal muscle protein pools (myofibrillar, sarcoplasmic and collagen), both following resistance… 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?
- Leucine enriched amino acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to Aug 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
- Healthy, male and female, recreationally-active participants.
- Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix B).
- Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
- Participants will be aged 18-35 years old.
- Participants are willing to abide by the compliance rules of this study.
- Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).
Who cannot join
- Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor.
- Self-reported regular tobacco use.
- Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
- Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
- Use of birth control and discontinued use within the last 3 months (female participants).
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
Official title: Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis in Human Skeletal Muscle
The primary objective will be to determine the effect of leucine-enriched essential amino acids (LEAA) compared to carbohydrate placebo on dietary incorporation of [D5] Phenylalanine \& [D5] Glycine into the three skeletal muscle protein pools (myofibrillar, sarcoplasmic and collagen), both following resistance exercise and at rest, with the two tracers provided as a 'intrinsically labeled' bolus. Other outcomes will relate to molecular regulation of protein synthesis.
- Conditions
- Interventional
- Being tested
- Leucine enriched amino acids, Carbohydrate Placebo
- Keywords
- Leucine-enriched amino acids, Carbohydrate Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine enriched amino acidsDietary supplement
Also called LEAA
Leucine enriched essential amino acids (4g total, of which 1.6g are leucine). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda.
Carbohydrate PlaceboDietary supplement
iso-caloric placebo (4g maltodextrin). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda.
| Study group | Role | What they receive |
|---|---|---|
| Leucine enriched essential amino acids | Active comparator | Leucine enriched essential amino acids (4g total, of which 1.6g are leucine). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda to mask taste. Receives: Dietary Supplement: Leucine enriched amino acids |
| Carbohdyrate Placebo | Placebo comparator | Iso-caloric placebo (4g maltodextrin to replace LEAA). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda to mask taste. Receives: Dietary Supplement: Carbohydrate Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar Protein synthesis
Rate of incorporation of orally ingested amino acid tracers (D5 Phe and D5 Gly) into myofibrillar proteins isolated from skeletal muscle biopsies 4h following drink (LEAA or PLA) consumption and resistance exercise or at rest. Enrichment will be quantified via tandem LC-MS/MS to derive a rate of incorporation over the 4h period.
Measured: 4 hours
Secondary outcomes (3)
Sarcoplasmic protein synthesis
Rate of incorporation of orally ingested amino acid tracers (D5 Phe and D5 Gly) into sarcoplasmic (i.e., soluble) proteins isolated from skeletal muscle biopsies 4h following drink consumption (LEAA or PLA) and resistance exercise or at rest. Enrichment will be quantified via tandem LC-MS/MS.
Measured: 4 hours
Collagen protein synthesis
Rate of incorporation of orally ingested amino acid tracers (D5 Phe and D5 Gly) into collagen (i.e., non-soluble) proteins isolated from skeletal muscle biopsies 4h following drink consumption (LEAA or PLA) and resistance exercise or at rest. Enrichment will be quantified via tandem LC-MS/MS.
Measured: 4 hours
Protein localization via immunofluorescence
Antibody-determined Phosphorylated RPS6 (S240/244) and mTOR protein localization in human muscle cross sections and longitudinal sections as examined via immunofluorescence. Muscle sections (both longitudinal and cross-sections) will be derived from snap-frozen muscle biopsies performed 4h following drink consumption (LEAA or PLA) with or without resistance exercise (unilateral). Localization will be performed as done by Hodson et al., (2022; AJP Cell). Particularly, the localization of these targets relative to the cell periphery and z-discs (longitudinal sections only) will be analyzed via colocalization analysis.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Oct 2022
- Primary completion3 Oct 2023
- Study completionAug 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.
- 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
- Crossover to receive LEAA or Carbohydrate placebo. Unilateral leg exercise to give 4 outcome. (1) LEAA-EX; (2) LEAA-REST; (3) PLACEBO-EX; (4) PLACEBO-REST
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Moore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554653
- Sponsor's protocol ID
- ULE
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2022
- Last updated
- 13 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT05554653
- Acronym / sponsor ID
- ULE
- Conditions
- Interventional
- Keywords
- Leucine-enriched amino acids, Carbohydrate Placebo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Daniel MooreUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Sep 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 primary objective will be to determine the effect of leucine-enriched essential amino acids (LEAA) compared to carbohydrate placebo on dietary incorporation of [D5] Phenylalanine \& [D5] Glycine into the three skeletal muscle protein pools (myofibrillar, sarcoplasmic and collagen), both following resistance exercise and at rest, with the two tracers provided as a 'intrinsically labeled' bolus. Other outcomes will relate to molecular regulation of protein synthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover to receive LEAA or Carbohydrate placebo. Unilateral leg exercise to give 4 outcome. (1) LEAA-EX; (2) LEAA-REST; (3) PLACEBO-EX; (4) PLACEBO-REST
| Arm | Type | Receives |
|---|---|---|
| Leucine enriched essential amino acids | Active comparator | Dietary Supplement: Leucine enriched amino acidsLeucine enriched essential amino acids (4g total, of which 1.6g are leucine). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda to mask taste. |
| Carbohdyrate Placebo | Placebo comparator | Dietary Supplement: Carbohydrate PlaceboIso-caloric placebo (4g maltodextrin to replace LEAA). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda to mask taste. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, male and female, recreationally-active participants.
- Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix B).
- Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
- Participants will be aged 18-35 years old.
- Participants are willing to abide by the compliance rules of this study.
Key exclusion criteria (5 listed)
- Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor.
- Self-reported regular tobacco use.
- Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
- Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
- Use of birth control and discontinued use within the last 3 months (female participants).
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 |
|---|---|---|
| Leucine enriched amino acidsAlso: LEAALeucine enriched essential amino acids (4g total, of which 1.6g are leucine). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda. | Dietary supplement | Leucine enriched essential amino acids |
| Carbohydrate Placeboiso-caloric placebo (4g maltodextrin). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda. | Dietary supplement | Carbohdyrate Placebo |
Primary outcome
Myofibrillar Protein synthesis
Time frame: 4 hours
Rate of incorporation of orally ingested amino acid tracers (D5 Phe and D5 Gly) into myofibrillar proteins isolated from skeletal muscle biopsies 4h following drink (LEAA or PLA) consumption and resistance exercise or at rest. Enrichment will be quantified via tandem LC-MS/MS to derive a rate of incorporation over the 4h period.
3 secondary outcomes
Sarcoplasmic protein synthesis
Time frame: 4 hours
Collagen protein synthesis
Time frame: 4 hours
Protein localization via immunofluorescence
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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 Leucine enriched amino acids in people with Interventional, run by Daniel Moore 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 6 inclusion and 5 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 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. Some participants in this study may receive a placebo. 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?
Myofibrillar Protein synthesis (time frame: 4 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 13 Nov 2023.