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NCT07715201
A Pilot Study of HME Amino Acid Supplementation on Strength, Performance, and Recovery in Trained Adult Males
Conditions: Muscle Strength, Athletic Performance, Resistance Training
Sex: Male
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: Orivian inc
Location: The Institute of Human Mechanics/ JUNXION Performance Toronto Ontario
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.
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)
Source: ClinicalTrials.gov (NCT07715201). StuddyBuddy aggregates publicly available trial information.