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.
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
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
Crossover
Alpha Brain proprietary cognitive dietary supplement
Dietary supplementAlpha Brain is a proprietary investigational dietary supplement. The formulation contains a combination of dietary ingredients commonly used in cognitive supplement mixes.
Alpha Brain 2.0 proprietary cognitive dietary supplement
Dietary supplementAlpha Brain 2.0 is a proprietary investigational dietary supplement. The formulation contains a combination of dietary ingredients commonly used in cognitive supplements and will be evaluated under double-blind conditions in a randomized, placebo-controlled crossover study.
Controlled Placebo
Dietary supplementThe placebo consists of an inactive placebo mix administered orally as two capsules.
Psychomotor Vigilance Test
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
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.
Stroop
Subjects will complete the Stroop task electronically using the Milliseconds platform for cognitive assessment. Stroop is designed to measure executive function, cognitive flexibility, and response inhibition. It includes three conditions: simple reaction to color words, matching color and word, and identifying mismatched color-word combinations. Key metrics include simple and complex reaction times and commission errors. Faster reaction times and fewer errors reflect stronger executive control, while delayed times or errors may indicate cognitive slowing, impulsivity, or difficulty inhibiting automatic responses.
Abbreviated Profile of Mood States Questionnaire
Subjects will complete The Abbreviated Profile of Mood States (POMS) as an electronic 40-item self-report instrument used to assess an individual's transient emotional state across seven distinct dimensions: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, Confusion-Bewilderment, Vigor-Activity (Energy), and Esteem-Related Affect. Each item is rated on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"). Domain scores are calculated by summing item responses within each subscale. A Total Mood Disturbance (TMD) score is computed as the sum of negative mood domains (Tension, Depression, Anger, Fatigue, and Confusion) minus the sum of positive mood domains (Vigor and Esteem-Related Affect). A constant of 100 is added to the TMD score to eliminate negative values, resulting in a total score range of 0 to 200. Higher TMD scores indicate greater overall mood disturbance, whereas lower scores indicate a more favorable mood state.
Heart Rate
Heart Rate (HR) is a secondary outcome measure in the study, assessed to ensure cardiovascular safety in participants subjected to sleep-restricted cognitive load. They will be taken using a pulse oximeter for heart rate.
Blood Pressure
Blood Pressure (BP) is asecondary outcome measure in the study, assessed to ensure cardiovascular safety in participants subjected to sleep-restricted cognitive load. They will be taken using a standard blood pressure cuff, and a monitor for blood pressure measurements.
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