Recruiting

HME

Sponsor:

Orivian inc

Code:

NCT07715201

Conditions

Muscle Strength

Athletic Performance

Resistance Training

Eligibility Criteria

Sex: Male

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

HME (Human Muscle Equivalent)

Placebo

Study Details

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.

Conditions

Muscle Strength

Athletic Performance

Resistance Training

Study ID

NCT07715201

Start date

Jun 29, 2026

Status verified date

Jul, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Dec 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 45

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: HME

HME (powder plus slow-release tablet/capsule together) at its licensed dose, once daily for 10 weeks. Taken post-workout on training days and in the morning on rest days.

placebo comparator: Placebo

Maltodextrin powder and one maltodextrin capsule, matched to HME for appearance, volume, and taste; identical timing and instructions.

Interventions

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).

Placebo

Maltodextrin powder and capsule matched for appearance, volume, and taste.

Primary outcome measure

  • Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press) [ Time Frame: Week 2 (baseline) to Week 10 ]

Central Contacts and Locations

Central contacts

Reza Ardekani, MD

+1(647)468-2225reza.ardekani.md@gmail.com

Locations

The Institute of Human Mechanics/ JUNXION Performance

Recruiting

Toronto, Ontario, Canada, M8Z 2R4

Contacts

Reza Ardekani

+1(647)468-2225reza.ardekani.md@gmail.com

More Information

Sponsor

Orivian inc

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • amino acids
  • human muscle equivalent
  • dietary supplement
  • HME
  • body composition
  • recovery
  • sports nutrition
  • 1-RM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orivian inc on 2026-07-23.