Muscle StrengthNCT07715201
HME Amino Acid Supplementation for Strength, Performance, and Recovery in Trained Adult Males
A study testing HME (Human Muscle Equivalent) in people with Muscle Strength and Athletic Performance, run by Orivian inc at 1 site in Canada.
Trial summary
This pilot randomized controlled trial evaluates HME (Human Muscle Equivalent), a free-form amino acid supplement formulated to match the amino acid composition of human skeletal muscle, taken at its Health Canada licensed dose (3 g powder plus one 50 mg slow-release beta-alanine capsule daily). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Athletic Performance, Resistance Training
- What is being tested?
- HME (Human Muscle Equivalent)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jun 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45 years inclusive
- Biological male
- Active competitive athlete in a recognized sport OR certified fitness professional (personal trainer, strength and conditioning coach, or equivalent)
- Minimum 3 structured resistance-training sessions per week for at least 1 year continuously
- Habitual protein intake 1.2 to 2.0 g/kg/day confirmed by 7-day food diary at screening
- Current creatine users willing to use study-provided creatine monohydrate 5 g/day; non-users willing not to initiate creatine during the trial
Show all 9Show fewer
- Able to provide written informed consent in English
- Willing and able to attend all supervised training sessions and assessment visits for 10 weeks
- Access to a digital kitchen scale or willing to obtain one for food-record completion
Who cannot join
- Use of anabolic steroids, SARMs, prohormones, or beta-alanine supplements (other than the study product) within 8 weeks of screening
- Current use of any amino acid supplement or weight-gainer product not cleared by the research coordinator
- Currently in an active competitive season with non-negotiable training demands the investigator determines are incompatible with the supervised programme
- Musculoskeletal injury in the preceding 3 months affecting ability to perform study assessments or training
- Any medical condition, medication, or dietary restriction that in the Medical Officer's opinion would affect the safety or validity of participation
- Participation in another intervention study within 4 weeks of screening
- Unwillingness to standardize creatine intake per protocol (current users) or to abstain from initiating creatine (non-users)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Institute of Human Mechanics/ JUNXION Performance
Toronto, Ontario, M8Z 2R4
Reza Ardekani, +1(647)468-2225, reza.ardekani.md@gmail.com
About this study
Official title: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial of HME (Human Muscle Equivalent) Supplementation on Strength, Body Composition, Athletic Performance, and Recovery in Trained Adults
This pilot randomized controlled trial evaluates HME (Human Muscle Equivalent), a free-form amino acid supplement formulated to match the amino acid composition of human skeletal muscle, taken at its Health Canada licensed dose (3 g powder plus one 50 mg slow-release beta-alanine capsule daily). Trained adult males (competitive athletes or certified fitness professionals) are randomized to HME or an identical-appearing placebo for 10 weeks: a 2-week supplement-only lead-in followed by 8 weeks of supplement plus supervised resistance training. The primary aim is to estimate the effect of HME on composite maximal strength (1-repetition maximum leg press plus chest press) compared with placebo. Secondary measures include isometric knee-extension strength, countermovement jump height, and subjective recovery.
Read the detailed description
This is a parallel-group, double-blind, placebo-controlled pilot RCT conducted in Toronto, Ontario, Canada. Target enrollment is 40 to 50 trained adult males (20 to 25 per arm), each meeting a minimum threshold of at least 3 structured resistance-training sessions per week for at least 1 year. Participants are randomized using variable block sizes (4 and 6) with no stratification, drawn from a single homogeneous high-performance population.
The intervention arm receives HME at its licensed dose (3 g free-form amino acid powder plus one 50 mg slow-release beta-alanine capsule daily); the placebo arm receives a maltodextrin powder and capsule matched for appearance, volume, and taste. Creatine is standardized as an open-label background supplement common to both arms (current users receive study-provided creatine monohydrate 5 g/day; non-users abstain), recorded as a covariate.
The trial comprises a 2-week supplement-only lead-in (habitual training) followed by an 8-week supervised resistance-training phase (3 sessions/week). Assessments occur at Weeks 0, 2, 3, 6, and 10. Week 2 (end of lead-in) serves as the pre-exercise baseline for the primary outcome; the Week 0 to Week 2 change estimates a supplement-only signal. Participants, assessors, and the statistical analyst are blinded; blinding integrity is monitored via the Bang Blinding Index at Weeks 2, 6, and 10. The primary analysis is a linear mixed model testing the Group by Time interaction on composite 1-RM (intention-to-treat), adjusting for baseline strength, dietary protein intake, training load, and dietary pattern.
- Conditions
- Muscle Strength, Athletic Performance, Resistance Training
- Being tested
- HME (Human Muscle Equivalent), Placebo
- Keywords
- amino acids, human muscle equivalent, dietary supplement, HME, body composition, recovery, sports nutrition, 1-RM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HME (Human Muscle Equivalent)Dietary supplement
HME (Human Muscle Equivalent) is a two-component amino acid formulation taken together as a single daily serving: a 3 g free-form amino acid powder matched to the human skeletal muscle amino acid profile, plus a slow-release capsule containing 50 mg beta-alanine. Both components together constitute HME. Health Canada NPN 80148183 (powder) and 80148185 (capsule).
PlaceboDietary supplement
Maltodextrin powder and capsule matched for appearance, volume, and taste.
| Study group | Role | What they receive |
|---|---|---|
| HME | Experimental | HME (powder plus slow-release tablet/capsule together) at its licensed dose, once daily for 10 weeks. Taken post-workout on training days and in the morning on rest days. Receives: Dietary Supplement: HME (Human Muscle Equivalent) |
| Placebo | Placebo comparator | Maltodextrin powder and one maltodextrin capsule, matched to HME for appearance, volume, and taste; identical timing and instructions. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press)
Sum of maximal leg press and seated chest press, analyzed by linear mixed model (Group by Time), intention-to-treat.
Measured: Week 2 (baseline) to Week 10
Secondary outcomes (6)
Countermovement jump height
CMJ height (cm), Jump pad measured, best of 3 attempts.
Measured: Weeks 0, 2, 3, 6, 10
Delayed-onset muscle soreness (DOMS)
DOMS visual analogue scale (0 to 10), weekly self-report.
Measured: weekly from weeks 1 to 10
Subjective recovery (Hooper Index)
Hooper Index total and 4 subscales (fatigue, sleep quality, stress, muscle soreness), 1 to 7 Likert each, weekly self-report.
Measured: Weekly, Weeks 1 to 10
Isometric knee-extension peak force
Peak force (N/kg), VOLTRA I isometric mode, 90/90 seated position, single blinded assessor.
Measured: Weeks 0, 2, 3, 6, 10
Isometric knee-extension rate of force development
Rate of force development 0 to 100 ms (N/s), VOLTRA I isometric mode.
Measured: Weeks 0, 2, 3, 6, 10
Blinding integrity (Bang Blinding Index)
Bang Blinding Index to assess blinding integrity; sensitivity analysis triggered if index exceeds 0.25.
Measured: Weeks 2, 6, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start29 Jun 2026
- Primary completion29 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orivian inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reza Ardekani, MD PhD, Principal investigator, Orivian incAnthony Galea, MD, Principal investigator, The Institute of Human Mechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715201
- Sponsor's protocol ID
- ORIVIAN-HME-95507
- Other IDs
- Pro00095507, NPN 80148183, NPN 80148185
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared. Aggregate results will be reported in accordance with CONSORT 2010.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Double-Blind, Placebo-Controlled Trial of HME (Human Muscle Equivalent) Supplementation on Strength, Body Composition, Athletic Performance, and Recovery in Trained Adults
- ClinicalTrials.gov ID
- NCT07715201
- Acronym / sponsor ID
- ORIVIAN-HME-95507
- Conditions
- Muscle Strength, Athletic Performance, Resistance Training
- Keywords
- amino acids, human muscle equivalent, dietary supplement, HME, body composition, recovery, sports nutrition, 1-RM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Orivian incIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 20 Jul 2026 (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 pilot randomized controlled trial evaluates HME (Human Muscle Equivalent), a free-form amino acid supplement formulated to match the amino acid composition of human skeletal muscle, taken at its Health Canada licensed dose (3 g powder plus one 50 mg slow-release beta-alanine capsule daily). Trained adult males (competitive athletes or certified fitness professionals) are randomized to HME or an identical-appearing placebo for 10 weeks: a 2-week supplement-only lead-in followed by 8 weeks of supplement plus supervised resistance training. The primary aim is to estimate the effect of HME on composite maximal strength (1-repetition maximum leg press plus chest press) compared with placebo. Secondary measures include isometric knee-extension strength, countermovement jump height, and subjective recovery.
Detailed description
This is a parallel-group, double-blind, placebo-controlled pilot RCT conducted in Toronto, Ontario, Canada. Target enrollment is 40 to 50 trained adult males (20 to 25 per arm), each meeting a minimum threshold of at least 3 structured resistance-training sessions per week for at least 1 year. Participants are randomized using variable block sizes (4 and 6) with no stratification, drawn from a single homogeneous high-performance population.
The intervention arm receives HME at its licensed dose (3 g free-form amino acid powder plus one 50 mg slow-release beta-alanine capsule daily); the placebo arm receives a maltodextrin powder and capsule matched for appearance, volume, and taste. Creatine is standardized as an open-label background supplement common to both arms (current users receive study-provided creatine monohydrate 5 g/day; non-users abstain), recorded as a covariate.
The trial comprises a 2-week supplement-only lead-in (habitual training) followed by an 8-week supervised resistance-training phase (3 sessions/week). Assessments occur at Weeks 0, 2, 3, 6, and 10. Week 2 (end of lead-in) serves as the pre-exercise baseline for the primary outcome; the Week 0 to Week 2 change estimates a supplement-only signal. Participants, assessors, and the statistical analyst are blinded; blinding integrity is monitored via the Bang Blinding Index at Weeks 2, 6, and 10. The primary analysis is a linear mixed model testing the Group by Time interaction on composite 1-RM (intention-to-treat), adjusting for baseline strength, dietary protein intake, training load, and dietary pattern.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HME | Experimental | Dietary Supplement: HME (Human Muscle Equivalent)HME (powder plus slow-release tablet/capsule together) at its licensed dose, once daily for 10 weeks. Taken post-workout on training days and in the morning on rest days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin powder and one maltodextrin capsule, matched to HME for appearance, volume, and taste; identical timing and instructions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 45 years inclusive
- Biological male
- Active competitive athlete in a recognized sport OR certified fitness professional (personal trainer, strength and conditioning coach, or equivalent)
- Minimum 3 structured resistance-training sessions per week for at least 1 year continuously
- Habitual protein intake 1.2 to 2.0 g/kg/day confirmed by 7-day food diary at screening
Key exclusion criteria (7 listed)
- Use of anabolic steroids, SARMs, prohormones, or beta-alanine supplements (other than the study product) within 8 weeks of screening
- Current use of any amino acid supplement or weight-gainer product not cleared by the research coordinator
- Currently in an active competitive season with non-negotiable training demands the investigator determines are incompatible with the supervised programme
- Musculoskeletal injury in the preceding 3 months affecting ability to perform study assessments or training
- Any medical condition, medication, or dietary restriction that in the Medical Officer's opinion would affect the safety or validity of participation
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 |
|---|---|---|
| HME (Human Muscle Equivalent)HME (Human Muscle Equivalent) is a two-component amino acid formulation taken together as a single daily serving: a 3 g free-form amino acid powder matched to the human skeletal muscle amino acid profile, plus a slow-release capsule containing 50 mg beta-alanine. Both components together constitute HME. Health Canada NPN 80148183 (powder) and 80148185 (capsule). | Dietary supplement | HME |
| PlaceboMaltodextrin powder and capsule matched for appearance, volume, and taste. | Dietary supplement | Placebo |
Primary outcome
Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press)
Time frame: Week 2 (baseline) to Week 10
Sum of maximal leg press and seated chest press, analyzed by linear mixed model (Group by Time), intention-to-treat.
6 secondary outcomes
Countermovement jump height
Time frame: Weeks 0, 2, 3, 6, 10
Delayed-onset muscle soreness (DOMS)
Time frame: weekly from weeks 1 to 10
Subjective recovery (Hooper Index)
Time frame: Weekly, Weeks 1 to 10
Isometric knee-extension peak force
Time frame: Weeks 0, 2, 3, 6, 10
Isometric knee-extension rate of force development
Time frame: Weeks 0, 2, 3, 6, 10
Blinding integrity (Bang Blinding Index)
Time frame: Weeks 2, 6, 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared. Aggregate results will be reported in accordance with CONSORT 2010.
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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.
Reza Ardekani, MD PhD principal investigator
Orivian inc
Anthony Galea, MD principal investigator
The Institute of Human Mechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HME (Human Muscle Equivalent) in people with Muscle Strength and Athletic Performance, run by Orivian inc 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Ardekani, MD (+1(647)468-2225, reza.ardekani.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press) (time frame: Week 2 (baseline) to Week 10). 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 23 Jul 2026.