Safety and Efficacy Study of Qualia Mind on Cognition in a Healthy Population
Condition: Healthy; Cognitive Function
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled, crossover study designed to
      investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult population
      between ages of 18 and 75 years. Qualia Mind is a nootropic supplement containing a complex
      mixture of vitamins, minerals, amino acids, choline donors, and herbal ingredients. These
      components have been demonstrated to exert their cognitive effects through distinct
      mechanisms of action involving cholinergic, glutamatergic, and dopaminergic receptor
      signalling; neuroplasticity; and modulation of cell membrane structure and metabolism.
    

Detailed description: 
      Qualia Mind is a nootropic supplement containing a complex mixture of vitamins, minerals,
      amino acids, choline donors, and herbal ingredients. These components have been demonstrated
      to exert their cognitive effects through distinct mechanisms of action involving cholinergic,
      glutamatergic, and dopaminergic receptor signalling; neuroplasticity; and modulation of cell
      membrane structure and metabolism. Vitamin B6 and B12 supplementation have been shown to
      improve cognitive scores related to memory in healthy participants aged 20 to 92 years.
      Twenty-eight days of B vitamin complex and vitamin C supplementation increased subjective
      ratings of concentration, mental stamina, and alertness. Although each B vitamin may exert
      differential effects on cognition, a higher intake of B vitamins throughout adulthood is
      associated with greater cognitive function later in life. An acute dose of CDP-choline
      improved processing speed, memory, verbal learning, and executive functioning in healthy
      participants who were poor performers on tests at baseline. Cognitive improvement among all
      participants may have been observed with repeated administration. It is also expected that
      with the additional administration of uridine monophosphate (UMP) and docosahexaenoic acid
      (DHA), a long-chain polyunsaturated fatty acid, would have a greater effect on cognitive
      performance based on preclinical studies describing a synergistic effect between the
      ingredients. Phosphatidylserine (PS) daily supplementation has strong clinical support for
      use in healthy humans for enhancing cognition and maintaining cognitive baseline performance.
      Moreover, the cognitive effects of Ginkgo biloba were found to be superior when complexed
      with PS. A specific extract of the herbal adaptogen, Bacopa monnieri, prepared from stems,
      leaves, and roots of the plant has been shown in healthy populations to enhance cognition by
      improving memory recall, selective attention, and processing speed. Rhodiola rosea, another
      herbal adaptogen, improved speed, and accuracy, compared to placebo, in a choice reaction
      time task using an extract derived from roots of the plant following a 4-week supplementation
      period. Examination of individual and synergistic effects of theobromine and caffeine in
      preclinical and clinical studies have been generally positive. Several doses of theobromine
      with caffeine have been shown to improve alertness, working memory, and other cognitive
      facets. Caffeine in combination with L-theanine has also been demonstrated to improve
      processing speed and accuracy in an attention-switching task, while improving concentration
      in a memory task. Other ingredients, such as Celastrus paniculatus, and pyrroloquinoline
      quinone have preclinical evidence supporting their positive effect on cognition that warrants
      further investigations in the form of clinical trials.

      A previous open-label study in a healthy population consuming Qualia Mind for 5 days assessed
      cognition using the Cambridge Brain Science Test and found significant improvements in
      memory, concentration, reasoning, and planning skills compared to baseline. Participants
      reported a significant 85% improvement in concentration after 5 days of supplementation.
      These promising preliminary results, however, require placebo-controlled studies to aid their
      interpretation.

      While the interest in enhancing cognitive performance is growing along with the use of brain
      health supplements, it is important to establish the safety and efficacy of nootropic
      supplements. Prescription and prohibited stimulant drugs intended to enhance mental
      performance have been increasing in usage worldwide. In 2017, results from the Global Drug
      Survey found that 14% of respondents reported using stimulants at least once in the last 12
      months, an increase from the 5% reported in the previous year. In the US alone, the use of
      drugs specifically for cognitive enhancement rose from 20 to 30%. These individuals seeking
      out cognitive enhancement primarily used prescription drugs, that are designed for
      individuals with Attention Deficit Hyperactivity Disorder (ADHD), such as the popular
      methylphenidate (Ritalin) or amphetamine-dextroamphetamine (Adderall).

      However, the evidence that these drugs enhance cognition in individuals without ADHD is
      lacking. Moreover, the misuse of stimulants is associated with adverse effects, such as
      psychosis, anorexia, cardiovascular events, and sudden death. The alternative nootropic
      industry of cognitive enhancers is a safe and legal substitute, with supplements designed
      specifically for healthy individuals. It is likely that stimulant misuse and associated
      adverse effects will be reduced, with the growing popularity and availability of clinically
      proven nootropics.

      Based on the existing evidence on individual ingredients and preliminary studies on Qualia
      Mind, the current randomized, double-blind, placebo-controlled, crossover study is designed
      to investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult
      population between ages of 18 and 75 years.

      ETHICAL ASPECTS OF THE STUDY

      This study will be conducted with the highest respect for the individual participants (i.e.,
      participants) according to the protocol, the ethical principles that have their origin in the
      Declaration of Helsinki, and the ICH Harmonised Tripartite Guideline for GCP.

      STATISTICAL EVALUATION

      Analysis Plan

      The Safety Population will consist of all participants who received any amount of either
      product and on whom any post-randomization safety information is available.

      The Intent-to-Treat (ITT) Population consists of all participants who received either product
      and on whom any post-randomization efficacy information is available.

      The Per Protocol (PP) Population consists of all participants who consumed at least 80% of
      treatment or placebo doses, do not have any major protocol violations and complete all study
      visits and procedures connected with measurement of the primary variable.

      Statistical Analysis Plan

      All hypothesis testing will be carried out at the 5% (2-sided) significance level unless
      otherwise specified.

      All data will be summarised by study group and/or visit. For continuous variables, the
      minimum and maximum, the arithmetic mean, median and standard deviation will be presented to
      two decimal places. For categorical variables, counts and percentages will be described. The
      denominator for each percentage will be the number of subjects within the population study
      group unless otherwise specified.

      The formula for the changes of continuous endpoints from screening/baseline:

      Change to Vi = Value at Vi - Value at V screening/baseline For the primary outcomes, analysis
      of covariance (ANCOVA) will be conducted for the evaluation of the change from baseline to
      the follow-up visit. The model will include period, group and sequence as fixed effects.
    

Intervention name(s): Qualia Mind; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Multi-ingredient Dietary supplement; Multi-ingredient Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cognition; Nootropic; Dietary Supplement; Healthy; Cambridge Brain Science Test