The Acute Effects of Onnit Alpha Brain on Cognition and Mood States: A Randomized, Crossover, Double Blind, Placebo-Controlled Trial
Applied Science & Performance Institute
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.
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 measu…
Eligibility
- Age range
- 20–59 years
- Sex
- All
- 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) assess…
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.
Location
- Applied Science Performance InstituteTampa, Florida