Sex-Divergent Effects of Magnesium L-Threonate Supplementation on Sleep Quality, Cognitive Performance Under Mental Fatigue, and Neuromuscular Function in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This study examined the effects of six weeks of magnesium L-threonate (MgT) supplementation on sleep quality, cognitive performance under experimentally induced mental fatigue, neuromuscular function, and psychophysiological outcomes in healthy adults. Biological sex and weight status were examined as pre-specified moderating variables.
详细描述
This study was a randomized, double-blind, placebo-controlled, parallel-group trial examining the effects of six weeks of magnesium L-threonate (MgT) supplementation on cognitive performance, mental fatigue, neuromuscular function, sleep quality, and psychophysiological outcomes in healthy adults. Biological sex and weight status were examined as pre-specified moderating variables given evidence for sex-specific differences in magnesium homeostasis and the elevated prevalence of magnesium inadequacy in individuals with overweight or obesity.
Participants:
Healthy male and female adults aged 18-45 years were recruited from a local university and surrounding community. Eighty-one participants were enrolled and randomized; the final analytic sample comprised 54 participants (MgT: n = 28; PLA: n = 26) following exclusions for non-adherence, technical data malfunction, and multivariate outlier removal. The sample was 59% female with a mean age of 23 ± 6 years and mean BMI of 26.7 ± 6.3 kg/m².
Intervention:
Participants assigned to the intervention group consumed 2 g·day-¹ of magnesium L-threonate (Magtein®; AIDP Inc., City of Industry, CA, USA) divided into two daily doses (morning and evening) for six weeks. Participants assigned to the placebo group consumed visually identical capsules containing rice powder (2 g·day-¹) on the same dosing schedule. Supplement compliance was assessed via capsule count at study conclusion; participants demonstrating less than 85% adherence were excluded from the final analytic sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Supplements were pre-labeled by batch number by an external party not involved in data collection. Capsules were visually identical in appearance. Group assignment was not disclosed to participants or study personnel until completion of all data collection and analysis.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults aged 18-45 years
- •Free from diagnosed neurological, cardiovascular, metabolic, or psychiatric conditions
- •Not currently taking medications or supplements known to influence cognitive or neuromuscular function
- •Willing to maintain habitual diet, physical activity, and sleep routines throughout the study period
排除标准
- •Pregnant or breastfeeding
- •Diagnosed sleep disorder
- •Initiated any new supplement or medication regimen within the past three months
- •Failed to meet ≥85% supplementation adherence threshold during the study (post-enrollment exclusion)
- •Technical data malfunction resulting in unrecoverable testing data (post-enrollment exclusion)
- •Identified as a multivariate outlier (values exceeding ±3 SD from the group mean on primary outcomes; post-enrollment exclusion)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline (Week 0) and post-intervention (Week 6)
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI; scored 0-21). Higher scores indicate poorer sleep quality. A score ≥5 indicates poor sleep quality.
Flanker Task Reaction Time
时间窗: Baseline (Week 0) and post-intervention (Week 6), assessed before and after a 20-minute mental fatigue induction protocol at each visit
Reaction time (ms) on the Incongruent Flanker Task assessed via computerized cognitive battery (SOMA platform). Lower values indicate faster processing.
Countermovement Jump Height
时间窗: Baseline (Week 0) and post-intervention (Week 6), assessed before and after a 20-minute mental fatigue induction protocol at each visit
Jump height (cm) assessed via dual force plates (VALD ForceDecks). Higher values indicate greater neuromuscular performance.
次要结局
- Flanker Task Processing Speed(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Flanker Task Rate Correct Score(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Flanker Task Coefficient of Variation(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Stroop Task Reaction Time(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Stroop Task Processing Speed(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Stroop Task Rate Correct Score(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Psychomotor Fatigue Test Reaction Time(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Psychomotor Fatigue Test Processing Speed(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Psychomotor Fatigue Test Rate Correct Score(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Task-Switching Test Reaction Time(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Task-Switching Test Processing Speed(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Task-Switching Test Rate Correct Score(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Time-Load Dual-Back Rate Correct Score(Baseline (Week 0) and post-intervention (Week 6))
- Countermovement Jump Peak Landing Force(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Countermovement Jump Reactive Strength Index(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Countermovement Jump Concentric Impulse(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction)
- Pittsburgh Sleep Quality Index - Global Score Change(Change from baseline (Week 0) to post-intervention (Week 6))
- Perceived Stress Scale (PSS)(Baseline (Week 0) and post-intervention (Week 6))
- State-Trait Anxiety Inventory - State Subscale (STAI-S)(Baseline (Week 0) and post-intervention (Week 6))
- State-Trait Anxiety Inventory - Trait Subscale (STAI-T)(Baseline (Week 0) and post-intervention (Week 6))
- Visual Analog Scale for Fatigue (VAS-F)(Baseline (Week 0) and post-intervention (Week 6), assessed before and after mental fatigue induction at each visit)
- NASA Task Load Index (NASA-TLX)(Baseline (Week 0) and post-intervention (Week 6), assessed immediately following mental fatigue induction)
研究者
Antonella Schwarz
Assistant Professor of Sport and Exercise Science
Barry University