HME amino acid supplement for strength and performance in trained adult men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled pilot trial conducted in Toronto. Trained adult males are assigned to either HME or a matched placebo for 10 weeks, including a 2-week lead-in and 8 weeks of supervised training, to see if the supplement plus training increases composite 1-RM strength more than placebo. Primary outcome is the change in combined leg press and chest press 1-RM; secondary outcomes include isometric knee extension strength, countermovement jump height, and self-reported recovery. Creatine use is allowed as a background variable and recorded. Assessments occur at multiple time points to quantify supplement-only and training-related effects, with blinding integrity checked throughout.

Why it matters

Who can join: the full rules

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)

Where it's running

• The Institute of Human Mechanics/ JUNXION Performance
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Reza Ardekani, MD PhD — Orivian inc
• Study coordinator: Reza Ardekani, MD
• Email: reza.ardekani.md@gmail.com
• Phone: +1(647)468-2225

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.