HME Amino Acid Supplementation for Strength, Performance, and Recovery in Trained Adult Males
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HME (Human Muscle Equivalent), Placebo.
- Who it may be relevant to
- Registry conditions: Muscle Strength, Athletic Performance, Resistance Training. Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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 supplement 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 Placebo
Maltodextrin powder and capsule matched for appearance, volume, and taste.
Primary outcome measures
- Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press) [Time frame: Week 2 (baseline) to Week 10]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Canada · 1 center
- The Institute of Human Mechanics/ JUNXION Performance — Toronto
Identifiers
NCT: NCT07715201 · ORIVIAN-HME-95507 · Pro00095507 · NPN 80148183 · NPN 80148185