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Recruiting
View on ClinicalTrials.gov

Testing HME (Human Muscle Equivalent) against a placebo for muscle strength

Official title: 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

Condition: Muscle StrengthSponsor: Orivian incTarget enrollment: 50
  • 2 groups
  • One site, in Toronto
  • Recruiting
The Institute of Human Mechanics/ JUNXION Performance, Toronto, Ontario

Interventions

  • Other intervention

    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).

  • Other intervention

    Placebo

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

Canadian Sites (1)

1 of 1 recruiting

  • The Institute of Human Mechanics/ JUNXION Performance

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for16 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age 18 to 45 years inclusive
  • +Habitual protein intake 1.2 to 2.0 g/kg/day confirmed by 7-day food diary at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
  • +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
  • +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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

  • Use of anabolic steroids, SARMs, prohormones, or beta-alanine supplements (other than the study product) within 8 weeks of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
  • 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more → (current users) or to abstain from initiating creatine (non-users)
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is investigating how something functions in the body, rather than testing a treatment directly.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives HME (Human Muscle Equivalent).

Registry label: A: HME

Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.

Registry label: B: Placebo

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 18 years to 45 years.

The study lists male participants only.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 50 people.

The study is currently expected to finish around March 2027.

The main measurement is taken over: Week 2 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →) to Week 10.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press) — measured over Week 2 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →) to Week 10.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07715201 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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).

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About PlaceboDietary supplement

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

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 45 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 45 years.

It lists male participants only.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Week 2 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →) to Week 10.

The study as a whole is currently expected to finish around 2027-03-30.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 50 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.