Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha Brain | Experimental | Alpha Brain investigational dietary supplement administered as two oral capsules with water |
|
| Alpha Brain 2.0 | Active Comparator | Alpha Brain 2.0 investigational dietary supplement administered as two oral capsules with water |
|
| Control Treatment | Placebo Comparator | Inactive/inert placebo capsules administered as two oral capsules with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Sikorski, PhD | Applied Science and Performance Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Science Performance Institute | Tampa | Florida | 33634 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34960030 | Background | 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. | |
| 34135805 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-blind, placebo-controlled crossover study
Not provided
Not provided
Not provided
| 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. |
|
| Controlled Placebo | Dietary Supplement | The placebo consists of an inactive placebo mix administered orally as two capsules. |
|
| 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. | 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. | 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. | 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. |
| 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. |
| 39683633 | Background | Kerksick CM. Acute Alpha-Glycerylphosphorylcholine Supplementation Enhances Cognitive Performance in Healthy Men. Nutrients. 2024 Dec 9;16(23):4240. doi: 10.3390/nu16234240. |
| 22025811 | 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. |
| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided