Athletic Performance, Muscle Strength, Resistance Training
Conditions
Keywords
amino acids, human muscle equivalent, dietary supplement, HME, body composition, recovery, sports nutrition, 1-RM
Brief 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). 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.
Interventions
DIETARY_SUPPLEMENTHME (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_SUPPLEMENTPlacebo
Maltodextrin powder and capsule matched for appearance, volume, and taste.
Sponsors
Orivian inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Countermovement jump height | Weeks 0, 2, 3, 6, 10 | CMJ height (cm), Jump pad measured, best of 3 attempts. |
| Delayed-onset muscle soreness (DOMS) | weekly from weeks 1 to 10 | DOMS visual analogue scale (0 to 10), weekly self-report. |
| Subjective recovery (Hooper Index) | Weekly, Weeks 1 to 10 | Hooper Index total and 4 subscales (fatigue, sleep quality, stress, muscle soreness), 1 to 7 Likert each, weekly self-report. |
| Isometric knee-extension peak force | Weeks 0, 2, 3, 6, 10 | Peak force (N/kg), VOLTRA I isometric mode, 90/90 seated position, single blinded assessor. |
| Isometric knee-extension rate of force development | Weeks 0, 2, 3, 6, 10 | Rate of force development 0 to 100 ms (N/s), VOLTRA I isometric mode. |
| Blinding integrity (Bang Blinding Index) | Weeks 2, 6, 10 | Bang Blinding Index to assess blinding integrity; sensitivity analysis triggered if index exceeds 0.25. |
Countries
Canada
Contacts
CONTACTReza Ardekani, MD
PRINCIPAL_INVESTIGATORReza Ardekani, MD PhD
Orivian inc
PRINCIPAL_INVESTIGATORAnthony Galea, MD
The Institute of Human Mechanics
Outcome results
None listed