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

NCT07495592 | Completed

• 1 other identifier: Pro00092553
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Executive Function (Cognition); Cognitive; Mood and Cognitive Performance; Sleep Deprivation

Keywords

Alpha Brain; Dietary Supplement; Reaction Time; Attention; Vigilance; Mood States; Psychomotor Vigilance Test; Stroop Test; alertness; Executive Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

Study Arms (3)

Alpha Brain

EXPERIMENTAL

Alpha Brain investigational dietary supplement administered as two oral capsules with water

Dietary Supplement: Alpha Brain proprietary cognitive dietary supplement

Alpha Brain 2.0

ACTIVE COMPARATOR

Alpha Brain 2.0 investigational dietary supplement administered as two oral capsules with water

Dietary Supplement: Alpha Brain 2.0 proprietary cognitive dietary supplement

Control Treatment

PLACEBO COMPARATOR

Inactive/inert placebo capsules administered as two oral capsules with water

Dietary Supplement: Controlled Placebo

Interventions

Controlled Placebo DIETARY_SUPPLEMENT

The placebo consists of an inactive placebo mix administered orally as two capsules.

Control Treatment

Alpha Brain proprietary cognitive dietary supplement DIETARY_SUPPLEMENT

Alpha Brain is a proprietary investigational dietary supplement. The formulation contains a combination of dietary ingredients commonly used in cognitive supplement mixes.

Alpha Brain

Alpha Brain 2.0 proprietary cognitive dietary supplement 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.

Alpha Brain 2.0

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science Performance Institute

Tampa, Florida, 33634, United States

Location

Related Publications (4)

• 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.

  PMID: 34960030 BACKGROUND

• 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.

  PMID: 34135805 BACKGROUND

• Kerksick CM. Acute Alpha-Glycerylphosphorylcholine Supplementation Enhances Cognitive Performance in Healthy Men. Nutrients. 2024 Dec 9;16(23):4240. doi: 10.3390/nu16234240.

  PMID: 39683633 BACKGROUND

• 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.

  PMID: 22025811 BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation; Fatigue

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Eric Sikorski, PhD

  Applied Science and Performance Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled crossover study

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion: June 26, 2026
• Study Completion: June 26, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)