HME Amino Acid Supplementation for Strength, Performance, and Recovery in Trained Adult Males

NCT07715201 | Recruiting

• 4 other identifiers: ORIVIAN-HME-95507Pro00095507NPN 80148183NPN 80148185
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  Week 2 (baseline) to Week 10

Secondary Outcomes (6)

• Countermovement jump height

  Weeks 0, 2, 3, 6, 10

• Delayed-onset muscle soreness (DOMS)

  weekly from weeks 1 to 10

• Subjective recovery (Hooper Index)

  Weekly, Weeks 1 to 10

• Isometric knee-extension peak force

  Weeks 0, 2, 3, 6, 10

• Isometric knee-extension rate of force development

  Weeks 0, 2, 3, 6, 10

Other Outcomes (2)

• Repeated sprint ability

  Weeks 0, 2, 3, 6, 10

• Lean mass trajectory (bioimpedance)

  Weekly, Weeks 1 to 10

Study Arms (2)

HME

EXPERIMENTAL

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.

Dietary Supplement: HME (Human Muscle Equivalent)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

HME (Human Muscle Equivalent) DIETARY_SUPPLEMENT

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).

HME

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Orivian inc: lead

Study Sites (1)

The Institute of Human Mechanics/ JUNXION Performance

Toronto, Ontario, M8Z 2R4, Canada

RECRUITING

Study Officials

• Reza Ardekani, MD PhD

  Orivian inc

  PRINCIPAL INVESTIGATOR

• Anthony Galea, MD

  The Institute of Human Mechanics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Ardekani, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)