CognitiveNCT07495592
The Acute Effects of Onnit Alpha Brain on Cognition and Mood States
A study testing Alpha Brain proprietary cognitive dietary supplement and Alpha Brain 2.0 proprietary cognitive dietary supplement in people with Cognitive and Mood and Cognitive Performance, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive, Mood and Cognitive Performance, Sleep Deprivation
- What is being tested?
- Alpha Brain proprietary cognitive dietary supplement and Alpha Brain 2.0 proprietary cognitive dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science Performance Institute
Tampa, Florida, 33634
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive, Mood and Cognitive Performance, Sleep Deprivation, Executive Function (Cognition), Fatigue
- Being tested
- Alpha Brain proprietary cognitive dietary supplement, Alpha Brain 2.0 proprietary cognitive dietary supplement, Controlled Placebo
- Keywords
- Alpha Brain, Dietary Supplement, Reaction Time, Attention, Vigilance, Mood States, Psychomotor Vigilance Test, Stroop Test, alertness, Executive Function
- Medical subject headings
- Sleep Deprivation, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Brain proprietary cognitive dietary supplementDietary 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 2.0 proprietary cognitive dietary supplementDietary 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.
Controlled PlaceboDietary supplement
The placebo consists of an inactive placebo mix administered orally as two capsules.
| Study group | Role | What they receive |
|---|---|---|
| Alpha Brain | Experimental | Alpha Brain investigational dietary supplement administered as two oral capsules with water Receives: 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 Receives: 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 Receives: Dietary Supplement: Controlled Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2026
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CognitiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sikorski, PhD, Principal investigator, Applied Science and Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495592
- Sponsor's protocol ID
- Pro00092553
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34960030Petrowski 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.
PubMed 34135805Kerksick CM. Acute Alpha-Glycerylphosphorylcholine Supplementation Enhances Cognitive Performance in Healthy Men. Nutrients. 2024 Dec 9;16(23):4240. doi: 10.3390/nu16234240.
PubMed 39683633Basner 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.
PubMed 22025811
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Onnit Alpha Brain on Cognition and Mood States: A Randomized, Crossover, Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07495592
- Acronym / sponsor ID
- Pro00092553
- Conditions
- Cognitive, Mood and Cognitive Performance, Sleep Deprivation, Executive Function (Cognition), Fatigue
- Keywords
- Alpha Brain, Dietary Supplement, Reaction Time, Attention, Vigilance, Mood States, Psychomotor Vigilance Test, Stroop Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| Alpha Brain | Experimental | Dietary Supplement: Alpha Brain proprietary cognitive dietary supplementAlpha Brain investigational dietary supplement administered as two oral capsules with water |
| Alpha Brain 2.0 | Active comparator | Dietary Supplement: Alpha Brain 2.0 proprietary cognitive dietary supplementAlpha Brain 2.0 investigational dietary supplement administered as two oral capsules with water |
| Control Treatment | Placebo comparator | Dietary Supplement: Controlled PlaceboInactive/inert placebo capsules administered as two oral capsules with water |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Brain proprietary cognitive dietary supplementAlpha Brain is a proprietary investigational dietary supplement. The formulation contains a combination of dietary ingredients commonly used in cognitive supplement mixes. | Dietary supplement | Alpha Brain |
| Alpha Brain 2.0 proprietary cognitive 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. | Dietary supplement | Alpha Brain 2.0 |
| Controlled PlaceboThe placebo consists of an inactive placebo mix administered orally as two capsules. | Dietary supplement | Control Treatment |
Primary outcome
Psychomotor Vigilance Test
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.
Samn-Perelli Subjective Fatigue Scale
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.
4 secondary outcomes
Stroop
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.
Abbreviated Profile of Mood States Questionnaire
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 34960030Xing 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.
- Background: PubMed 34135805Petrowski 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.
- Background: PubMed 39683633Kerksick CM. Acute Alpha-Glycerylphosphorylcholine Supplementation Enhances Cognitive Performance in Healthy Men. Nutrients. 2024 Dec 9;16(23):4240. doi: 10.3390/nu16234240.
- Background: PubMed 22025811Basner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sikorski, PhD principal investigator
Applied Science and Performance Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Brain proprietary cognitive dietary supplement and Alpha Brain 2.0 proprietary cognitive dietary supplement in people with Cognitive and Mood and Cognitive Performance, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Vigilance Test (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495592, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.