The Memory and Cognitive Performance Study
Condition: Cognitive Function; Memory; Brain Health
Study type: Interventional

Summary: 
      The primary purpose of this study is to evaluate the impact of a novel, neuro-protective and
      neuro-restorative dietary supplement (Braini®) on standardized memory and cognitive
      performance parameters. The principal active ingredients in the Braini® supplement have been
      commercially-available since at least 2015 or have achieved FDA new dietary ingredient
      notification (NDIN) in 2018, with no adverse events reported to the FDA.

      A 28-day randomized, double-blinded, placebo-controlled dietary supplement study will be
      conducted with a cohort of younger and a cohort of colder adults to achieve the purpose of
      this study. The research team hypothesizes that Braini® will improve standardized performance
      scores measured by CNS Vital Signs standard memory and cognitive performance assays more
      effectively than placebo.
    

Detailed description: 
      The number of people affected by cognitive decline continues to rise as the US population
      ages. A recent report indicates that this decline can be seen as early as age 45. Optimizing
      cognitive function during adulthood is a key mechanism to combat cognitive decline as one
      reaches older adulthood.

      Recent advances in cognitive wellness management have shown that tailored diet and lifestyle
      regimens that factor in various biomarkers and proclivities signaling cognitive decline (e.g.
      family genetics) can cause a person with a declining MOCA (measure of cognitive ability)
      score to restore or achieve an improved MOCA score.

      A number of clinical trials have studied nutraceutical ingredients for improved memory
      enhancement and/or cognitive performance. While the individual ingredients are already
      well-utilized in commerce globally, the Braini® formulation is novel, harnessing synergistic
      effects seen in a new in vitro human neural cell challenge study carried out in South Korea
      by the study sponsor. In this study a series of independent in vitro (cell line) tests of the
      active nutraceutical constituents that comprise the Braini® dietary supplement product line
      were performed. The tests follow current peer-reviewed published methods for assessing the
      effects of biologically active compounds on human neuronal cells. The in vitro study showed a
      significant improvement in cell viability and reactive oxygen species (ROS) inhibition using
      the Braini® compounds.

      Based on existing published science supporting the neuroprotective role of the Braini®
      formulation, this supplement may be useful and to improve cognitive function and health.
      Based on studies conducted outside the United States, the research team hypothesizes that
      orally ingested Braini® taken as directed (2 x 525 mg powdered capsules per day), will
      demonstrate superior improvements in standardized cognitive performance assays. MOCA scores
      will be used for screening patients. The research team aims to conduct a randomized,
      placebo-controlled, double-blinded dietary supplement study to evaluate this hypothesis among
      a cohort of younger and a cohort of older healthy adults.
    

Intervention name(s): Braini; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A novel, neuro-protective and neuro-restorative dietary supplement composed of a combination of active ingredients which have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) status in 2018; Matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Brain Health; Cognitive Abilities; Mental Orientation; Short-term Memory; Executive Function