The Acute Effects of Onnit Alpha Brain on Cognition and Mood States

The Acute Effects of Onnit Alpha Brain on Cognition and Mood States: A Randomized, Crossover, Double Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Sleep Deprivation; Cognitive; Mood and Cognitive Performance; Executive Function (Cognition)
• Intervention / Treatment: Dietary supplement: Alpha Brain proprietary cognitive dietary supplement; Dietary supplement: Alpha Brain 2.0 proprietary cognitive dietary supplement; Dietary supplement: Controlled Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Sikorski, PhD; Phone Number: 8138678888; Email: esikorski@theaspi.com
• Study Contact Backup: Name: Gabe Wilson, PhD; Phone Number: 8138678888; Email: gwilson@theaspi.com

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33634
      • Applied Science Performance Institute
      • Contact: Eric Sikorski, PhD; Phone Number: 8138678888; Email: esikorski@theaspi.com
      • Contact: Gabe Wilson, PhD; Phone Number: 8138678888; Email: gwilson@theaspi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha Brain; Alpha Brain investigational dietary supplement administered as two oral capsules with water	Dietary supplement: Alpha Brain proprietary cognitive dietary supplement; Alpha Brain is a proprietary investigational dietary supplement. The formulation contains a combination of dietary ingredients commonly used in cognitive supplement mixes.
Active Comparator: Alpha Brain 2.0; Alpha Brain 2.0 investigational dietary supplement administered as two oral capsules with water	Dietary supplement: Alpha Brain 2.0 proprietary cognitive dietary supplement; 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.
Placebo Comparator: Control Treatment; Inactive/inert placebo capsules administered as two oral capsules with water	Dietary supplement: Controlled Placebo; The placebo consists of an inactive placebo mix administered orally as two capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	Taken at all three visits, at baseline, and then repeated at 30 minutes, 60 minutes, 120 minutes, and 180 minutes post-supplementation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
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.	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.
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.	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.

Collaborators and Investigators

• Sponsor: Applied Science & Performance Institute
• Investigators: Principal Investigator: Eric Sikorski, PhD, Applied Science and Performance Institute

Publications and helpful links

General Publications

• Xing D, Yoo C, Gonzalez D, Jenkins V, Nottingham K, Dickerson B, Leonard M, Ko J, Faries M, Kephart W, Purpura M, Jager R, Wells SD, Sowinski R, Rasmussen CJ, Kreider RB. Dose-Response of Paraxanthine on Cognitive Function: A Double Blind, Placebo Controlled, Crossover Trial. Nutrients. 2021 Dec 15;13(12):4478. doi: 10.3390/nu13124478.
• Petrowski K, Albani C, Zenger M, Brahler E, Schmalbach B. Revised Short Screening Version of the Profile of Mood States (POMS) From the German General Population. Front Psychol. 2021 May 31;12:631668. doi: 10.3389/fpsyg.2021.631668. eCollection 2021.
• Kerksick CM. Acute Alpha-Glycerylphosphorylcholine Supplementation Enhances Cognitive Performance in Healthy Men. Nutrients. 2024 Dec 9;16(23):4240. doi: 10.3390/nu16234240.
• Basner M, Mollicone D, Dinges DF. Validity and Sensitivity of a Brief Psychomotor Vigilance Test (PVT-B) to Total and Partial Sleep Deprivation. Acta Astronaut. 2011 Dec 1;69(11-12):949-959. doi: 10.1016/j.actaastro.2011.07.015.

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Attention; Executive Function; Reaction Time; Dietary Supplement; alertness; Vigilance; Mood States; Stroop Test; Psychomotor Vigilance Test; Alpha Brain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue; Sleep Deprivation; alpha BRAIN
• Other Study ID Numbers: Pro00092553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No