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Completed

NCT Number: NCT04986956

Whole Coffee Cherry Study

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.

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Key information

Conditions

Effect of Drug

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole coffee cherry extract

Dietary Supplement

200mg WCCE

Other names: WCCE, CCE

Placebo

Dietary Supplement

Placebo for comparison to WCCE

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Collaborators

  • VDF FutureCeuticals Inc.

Registry information

Official study title

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

Acronym: WCCE

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Aug 3, 2021
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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