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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: HME (Human Muscle Equivalent) (Dietary Supplement)
Placebo
Maltodextrin powder and one maltodextrin capsule, matched to HME for appearance, volume, and taste; identical timing and instructions.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in composite 1-repetition maximum (1-RM) strength (leg press plus chest press)
时间窗: Week 2 (baseline) to Week 10
Sum of maximal leg press and seated chest press, analyzed by linear mixed model (Group by Time), intention-to-treat.
次要结局
- Isometric knee-extension rate of force development(Weeks 0, 2, 3, 6, 10)
- 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)
- Blinding integrity (Bang Blinding Index)(Weeks 2, 6, 10)