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

Applied Science & Performance Institute

Status: Begins enrollment this month

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

Treatments: Dietary Supplement: Alpha Brain proprietary cognitive dietary supplement; Dietary Supplement: Alpha Brain 2.0 proprietary cognitive dietary supplement; Dietary Supplement: Controlled Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07495592

Pro00092553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 3 patient groups, including a placebo group

Alpha Brain

Experimental group

Description:

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

Treatment:

Dietary Supplement: Alpha Brain proprietary cognitive dietary supplement

Alpha Brain 2.0

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Alpha Brain 2.0 proprietary cognitive dietary supplement

Control Treatment

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Controlled Placebo