Applied Science Performance Institute
Tampa, Florida, 33634, United States
NCT Number: NCT07495592
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.
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Notify Me20 year–59 year
All sexes
Interventional
Not applicable
Tampa, Florida, 33634, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Alpha 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 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.
The placebo consists of an inactive placebo mix administered orally as two capsules.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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 (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.
Applied Science & Performance Institute
Industry
The Acute Effects of Onnit Alpha Brain on Cognition and Mood States: A Randomized, Crossover, Double Blind, Placebo-Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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