Whole Coffee Cherry Study
Condition: Effect of Drug
Study type: Interventional

Summary: 
      There has been increasing interest in natural dietary supplements that may support healthy
      cognition. Recent studies have demonstrated promising effects of bioactive phytochemicals
      (e.g., polyphenols) on cardiovascular and endocrine health outcomes. As such, an increasingly
      intriguing line of inquiry is whether materials high in these compounds may also have effects
      on psychological measures. Preliminary evidence suggests that polyphenols may improve
      cognition, for example, particularly in aging populations. Whole coffee cherry extract (WCCE;
      otherwise known as the generally-recognized-as-safe (GRAS) supplement Neurofactor(TM)), is a
      proprietary, safe, powdered extract of whole coffee cherries from coffea arabica with high
      levels of polyphenols and substantially low (<2%; <4mg) levels of caffeine. WCCE has been
      previously associated with increased serum concentrations of both circulating and exosomal
      brain derived neurotrophic factor (BDNF), in addition to increased alertness and decreased
      fatigue. However, few well-powered and well-designed studies have been conducted despite the
      mounting preliminary evidence. Here, the investigators propose a study to examine the
      long-term effects of a 200mg dose of WCCE on measures of cognition.
    

Detailed description: 
      The investigators will conduct a virtual study whereby participants will be given either
      200mg WCCE or placebo to take every day for 28 days. Every 7 days, participants will take a
      cognitive assessment via the internet using a platform called Millisecond
      (https://www.millisecond.com/). The cognitive assessment will be composed of tasks that
      broadly test working memory, focus, and attention. Compliance checks will be administered
      daily via the participant's smartphone. This study will be conducted in a double-blind
      fashion, such that the experimental team and the participants are unaware of group assignment
      (200mg vs. placebo). Blinding information will be held by the study sponsor, VDF
      FutureCeuticals, Inc. Group assignment will be determined by random number generator, with
      restrictions to ensure equal group sizes, and equal distribution of males/females in each
      group. Participants, between 40-65 years of age, with no known psychiatric or neurological
      conditions, will be recruited from the general community via online advertisements, social
      media posts, community flyers, and newspaper ads (if needed). Participants will be excluded
      if they are taking medications known to alter cognitive functioning (psychotropic medications
      such as fluoxetine, benzodiazepines, etc. or other medications such as insulin). The primary
      variables of interest will be the behavioral performance on the cognitive tasks over time,
      inclusive of reaction time and accuracy. Compensation will be commensurate with study
      participation, with a maximum payout of $125.
    

Intervention name(s): Whole coffee cherry extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200mg WCCE; Placebo for comparison to WCCE
Other intervention name(s): WCCE; CCE
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two groups - study materials (whole coffee cherry extract (WCCE) or placebo).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: coffee cherry; cognition; virtual study; internet