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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
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).
Maltodextrin powder and capsule matched for appearance, volume, and taste.
The Institute of Human Mechanics/ JUNXION Performance
Toronto, Ontario, Canada
RECRUITINGChange 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.
Time frame: Week 2 (baseline) to Week 10
Countermovement jump height
CMJ height (cm), Jump pad measured, best of 3 attempts.
Time frame: Weeks 0, 2, 3, 6, 10
Delayed-onset muscle soreness (DOMS)
DOMS visual analogue scale (0 to 10), weekly self-report.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 2, 6, 10
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