Clinical trial NCT04986956: Whole Coffee Cherry Study
Official title: Longitudinal Study to Assess the Effects of Whole Coffee Cherry Extract (WCCE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Drug
Keywords: coffee cherry
cognition
virtual study
internet
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: VDF FutureCeuticals Inc.
First posted: 2021-08-03
Enrollment: 323
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups - study materials (whole coffee cherry extract (WCCE) or placebo).
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Between 40-65 years of age
* No diagnosed psychiatric or neurological condition
* Reliable internet service
* Moderate computer literacy
* Individuals must have a smartphone
* Individuals must have a laptop, desktop, or iPad

Exclusion Criteria:

* Individuals taking medications known to alter cognitive functioning (e.g., psychotropic medications such as fluoxetine, benzodiazepines, etc.)
* Individuals taking medications that alter metabolic function, such as insulin or metformin.
* Shift workers
* Health conditions that would prevent an individual from successfully completing the study (I.e., motor control conditions such as Parkinson's, or psychiatric conditions such as ADHD)
* Individuals with metabolic conditions
* Have had or currently have cancer
* Have taken CBD or multivitamins in the last 2 weeks
* Individuals with unreliable or no internet access/service
* Individuals who are unable to use a smartphone or are lacking the computer literacy necessary to complete the study remotely
* Individuals without a laptop, desktop or iPad that would prevent them from completing the study.

Primary outcomes:
measure: Behavioral Measures - Change in Go/NoGo Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in N-back Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in Face-Name Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in Stroop Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in Flanker Task Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in Symbol Search Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in Trail Making Reaction Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
measure: Behavioral Measures - Change in Face in the Crowd Time
timeFrame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Secondary outcomes:
measure: Daily Self-reported Sleep
timeFrame: The question will be administered daily for the duration of the study (approximately 28 days)
measure: Weekly Self-reported Sleep Hygiene
timeFrame: Questions are administered weekly for the duration of the study (approximately 28 days)
measure: Weekly Self-reported Mood
timeFrame: The questionnaire is administered weekly for the duration of the study (approximately 28 days)
measure: Daily Self-reported Mood
timeFrame: The question will be administered daily for the duration of the study (approximately 28 days)
Other outcomes:
measure: Compliance
timeFrame: Daily for the duration of the study (approximately 28 days)
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
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