Cognitive, Executive Function (Cognition), Fatigue, Mood and Cognitive Performance, Sleep Deprivation
Conditions
Keywords
Alpha Brain, Dietary Supplement, Reaction Time, Attention, Vigilance, Mood States, Psychomotor Vigilance Test, Stroop Test, alertness, Executive Function
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.
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.
Interventions
DIETARY_SUPPLEMENTAlpha 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.
DIETARY_SUPPLEMENTAlpha 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.
DIETARY_SUPPLEMENTControlled Placebo
The placebo consists of an inactive placebo mix administered orally as two capsules.
Sponsors
Applied Science & Performance Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, placebo-controlled crossover study
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Vigilance Test | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Sikorski, PhD
Applied Science and Performance Institute
Outcome results
None listed