The Acute Effects of Onnit Alpha Brain on Cognition and Mood States: A Randomized, Crossover, 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
- 32
- 试验地点
- 1
- 主要终点
- Psychomotor Vigilance Test
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled crossover study is to evaluate the efficacy of the acute effects of an investigational supplement (Alpha Brain or Alpha Brain 2.0) on improving cognitive performance, vigilance, and subjective mood in healthy adults compared to placebo during a period of acute sleep deprivation under conditions of controlled sleep deprivation.
详细描述
Participants will complete three experimental conditions in a randomized order: Alpha Brain, Alpha Brain 2.0, and placebo. To avoid any possible crossover bias created by ingesting the supplements, the subjects should be appropriately counterbalanced using six possible sequences that all subjects will be equally shuffled through to help limit any bias. Each condition will be separated by a minimum 3-day washout period. Participants will undergo standardized cognitive testing, mood assessments, and safety monitoring following overnight sleep restriction. Primary outcomes include objective measures of vigilance and cognitive control, while secondary outcomes include subjective fatigue, mood state, and physiological safety measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged 20-59
- •Free of chronic diseases.
- •Able to read and write in English
- •Willing to maintain a habitual diet, supplement routine, and avoid other lifestyle changes during the study period
- •Willingness to meet all study requirements and restrictions. Including willing to arrive in lab in a sleep deprived state (< or =5 hours), willing to avoid alcohol consumption 72 hours prior to testing days, and willing to avoid caffeine within 12 hours prior to testing days.
排除标准
- •Habitual high caffeine consumers (> 400 mg/day) assessed through caffeine assessment tool (Caffeine Consumption Questionnaire, CCQ)
- •Unwilling to wear sleep monitor at night
- •Known diagnosis of any cognitive impairment, cardiovascular, metabolic, endocrine, or renal disease
- •Has fever, or cold like symptoms
- •History of anxiety disorders
- •History of sleep disorders (i.e., insomnia), and habitually short sleepers (<5 hours of sleep nightly)
- •History or current malignancy
- •Previous gastrointestinal surgery within the past 12 months
- •No alcohol consumption 72 hours prior to the start of the study/consumption of the study product and during the testing days
- •No caffeine consumption within 12 hours prior to the start of the study and during the testing days
- •Sleep medicines, melatonin, or marijuana within 1 week of the start of the study
- •Regular smoker
- •Regular drinker (>14 drinks per week)
- •Current use (within the past 4 weeks) of dietary supplements or prescription medicines that may enhance cognitive performance (including, but not limited to L-Theanine, Cat's claw bark extract, Alpha GPC, Toothed clubmoss extract (Huperzine A), Bacopa, Phosphatidylserine, Paraxanthine, Pterostilbene, and Sceletium tortuosum).
- •Current use of prescription medications that may influence cognition (hormone therapies, peptides, etc.)
- •Travel involving time zone change, shift work, or other life events that alter sleep schedule >3 hours from the norm one week before the start of the study
- •Any subject with a condition deemed by the investigator or sponsor to potentially interfere with study participation
- •Women who have been pregnant within the past 6-months, are breastfeeding, lactating, or presently planning to become pregnant during the duration of the study
结局指标
主要结局
Psychomotor Vigilance Test
时间窗: Subjects will complete this on each of the three visits at baseline, and then repeated at 60 minutes, 120 minutes, and 180 minutes post supplementation.
Subjects will complete the Psychomotor Vigilance Test (PVT), a sustained-attention reaction time task administered electronically via the Milliseconds platform for cognitive assessmentThe PVT yields multiple performance metrics including mean reaction time (milliseconds), number of lapses (reaction times exceeding 500 ms), and number of errors. Lower mean reaction times and fewer lapses and errors indicate better attentional performance and reduced cognitive fatigue.
Samn-Perelli Subjective Fatigue Scale
时间窗: Taken at all three visits, at baseline, and then repeated at 30 minutes, 60 minutes, 120 minutes, and 180 minutes post-supplementation.
The Samn-Perelli Scale is a single-item self-report instrument used to assess subjective alertness and fatigue. Responses are recorded on a single-item scale from 1-7, with a left anchor (1) designated 'fully alert, wide awake' and the right anchor (7) designated 'completely exhausted, unable to function effectively'. This test is used to assess subjects' subjective experience of overall energy, alertness, fatigue, and mental clarity. Higher scores indicate greater fatigue and lower alertness.
次要结局
- Stroop(Subjects will complete this on each of the three visits at baseline, and then repeated at 60 minutes, 120 minutes, and 180 minutes post supplementation.)
- Abbreviated Profile of Mood States Questionnaire(Subjects will complete this on each of the three visits at baseline, and then repeated at 30 minutes, 120 minutes, and 180 minutes post supplementation.)
- Heart Rate(Subjects will complete this on each of the three visits at baseline, and then repeated at 30 minutes, 60 minutes, 120 minutes, and 180 minutes post supplementation.)
- Blood Pressure(Subjects will complete this on each of the three visits at baseline, and then repeated at 30 minutes, 60 minutes, 120 minutes, and 180 minutes post supplementation.)