Whole Coffee Cherry Study (WCCE)

January 29, 2024 updated by: Jennifer L. Robinson, Ph.D., Auburn University

Longitudinal Study to Assess the Effects of Whole Coffee Cherry Extract (WCCE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Auburn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products.
Dietary supplement: Placebo
Placebo for comparison to WCCE
Active Comparator: Whole coffee cherry extract
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. The only content of the supplement is WCCE - there are no excipients, binders, or flow agents, nor are there any other materials. The coffee cherry is subjected to a food-grade water ethanol extraction; thus, after extraction, only 100% coffee-based components remain. 200mg of WCCE will be administered daily for 28 days.
Dietary supplement: Whole coffee cherry extract
200mg WCCE
Other Names:
  • WCCE
  • CCE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Measures - Change in Go/NoGo Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in N-back Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction/accuracy time for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in Face-Name Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in Stroop Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in Flanker Task Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in Symbol Search Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in Trail Making Reaction Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Behavioral Measures - Change in Face in the Crowd Time
Time Frame: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)
Response/reaction time/accuracy for each stimuli will be recorded in ms using Inquisit. Reaction times will be calculated for correct and incorrect trials separately.
Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Self-reported Sleep
Time Frame: The question will be administered daily for the duration of the study (approximately 28 days)
The investigators will assess changes in the amount of sleep a participant had on a daily basis for the entire duration of the study via a single daily question asking about the number of hours of sleep the participant had the night before.
The question will be administered daily for the duration of the study (approximately 28 days)
Weekly Self-reported Sleep Hygiene
Time Frame: Questions are administered weekly for the duration of the study (approximately 28 days)
The investigators will assess changes in sleep via an in-house questionnaire (administered every 7 days for the entire length of the study) that inquires about the quality of sleep for the past 7 days, as well as how the participant would rate their sleep for the night prior to the assessment. These questions are scored as 1 = excellent, 2 = good, 3 = average, 4 = poor, and 5 = terrible.
Questions are administered weekly for the duration of the study (approximately 28 days)
Weekly Self-reported Mood
Time Frame: The questionnaire is administered weekly for the duration of the study (approximately 28 days)
The investigators will assess changes in mood every 7 days for the duration of the study. This questionnaire, developed in-house, asks about how often the participant has felt alert, focused, attentive, in-control, sleepy, determined, motivated, happy, and upset the participant has felt in the last 7 days. The scale is scored as 1 = always, 2 = most of the time, 3 = about half of the time, 4 = sometimes, and 5 = never.
The questionnaire is administered weekly for the duration of the study (approximately 28 days)
Daily Self-reported Mood
Time Frame: The question will be administered daily for the duration of the study (approximately 28 days)
The investigators will assess changes in mood via a daily question about how good/bad the participant feels on a scale of 0-100 (0 being worst they have ever felt, and 100 being the best they have ever felt).
The question will be administered daily for the duration of the study (approximately 28 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: Daily for the duration of the study (approximately 28 days)
The investigators will assess compliance via daily questionnaires delivered to the participant's smartphone.
Daily for the duration of the study (approximately 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auburn University

Collaborators

VDF FutureCeuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

January 29, 2024

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #21-219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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