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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Athletic Performance; Muscle Strength; Resistance Training
• Intervention / Treatment: Dietary supplement: HME (Human Muscle Equivalent); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reza Ardekani, MD; Phone Number: +1(647)468-2225; Email: reza.ardekani.md@gmail.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M8Z 2R4
      • Recruiting
      • The Institute of Human Mechanics/ JUNXION Performance
      • Contact: Reza Ardekani; Phone Number: +1(647)468-2225; Email: reza.ardekani.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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).
Placebo Comparator: Placebo; Maltodextrin powder and one maltodextrin capsule, matched to HME for appearance, volume, and taste; identical timing and instructions.	Dietary supplement: Placebo; Maltodextrin powder and capsule matched for appearance, volume, and taste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Countermovement jump height	CMJ height (cm), Jump pad measured, best of 3 attempts.	Weeks 0, 2, 3, 6, 10
Delayed-onset muscle soreness (DOMS)	DOMS visual analogue scale (0 to 10), weekly self-report.	weekly from weeks 1 to 10
Subjective recovery (Hooper Index)	Hooper Index total and 4 subscales (fatigue, sleep quality, stress, muscle soreness), 1 to 7 Likert each, weekly self-report.	Weekly, Weeks 1 to 10
Isometric knee-extension peak force	Peak force (N/kg), VOLTRA I isometric mode, 90/90 seated position, single blinded assessor.	Weeks 0, 2, 3, 6, 10
Isometric knee-extension rate of force development	Rate of force development 0 to 100 ms (N/s), VOLTRA I isometric mode.	Weeks 0, 2, 3, 6, 10
Blinding integrity (Bang Blinding Index)	Bang Blinding Index to assess blinding integrity; sensitivity analysis triggered if index exceeds 0.25.	Weeks 2, 6, 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeated sprint ability	Peak power, mean power, and fatigue index on cycle ergometer (5 x 6-second protocol, 7.5% body weight resistance). Exploratory.	Weeks 0, 2, 3, 6, 10
Lean mass trajectory (bioimpedance)	Lean mass trajectory by HumePod BIA under standardized hydration conditions. Budget-contingent, exploratory.	Weekly, Weeks 1 to 10

Collaborators and Investigators

• Sponsor: Orivian inc
• Investigators: Principal Investigator: Reza Ardekani, MD PhD, Orivian inc; Principal Investigator: Anthony Galea, MD, The Institute of Human Mechanics

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: recovery; body composition; dietary supplement; sports nutrition; amino acids; HME; human muscle equivalent; 1-RM
• Other Study ID Numbers: ORIVIAN-HME-95507; Pro00095507 (Other Identifier: Advarra IRB); NPN 80148183 (Other Identifier: Health Canada (HME powder)); NPN 80148185 (Other Identifier: Health Canada (beta-alanine tablet))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are not planned to be shared. Aggregate results will be reported in accordance with CONSORT 2010.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No