HME Amino Acid Supplementation for Strength, Performance, and Recovery in Trained Adult Males
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorOrivian inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HME (Human Muscle Equivalent)
Dietary supplementHME (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).
Placebo
Dietary supplementMaltodextrin powder and capsule matched for appearance, volume, and taste.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: HMEExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 2 (baseline) to Week 10Secondary outcomes
1
Countermovement jump height
CMJ height (cm), Jump pad measured, best of 3 attempts.
Time frame
Weeks 0, 2, 3, 6, 102
Delayed-onset muscle soreness (DOMS)
DOMS visual analogue scale (0 to 10), weekly self-report.
Time frame
weekly from weeks 1 to 103
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 104
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, 10Other outcomes
1
Repeated sprint ability
Peak power, mean power, and fatigue index on cycle ergometer (5 x 6-second protocol, 7.5% body weight resistance). Exploratory.
Time frame
Weeks 0, 2, 3, 6, 102
Lean mass trajectory (bioimpedance)
Lean mass trajectory by HumePod BIA under standardized hydration conditions. Budget-contingent, exploratory.
Time frame
Weekly, Weeks 1 to 10Sponsors and contacts
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Source ClinicalTrials.gov