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
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
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- 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.