AzTrials
AzTrials

Effect of DrugWCCENCT04986956

Whole Coffee Cherry Study

A study testing Whole coffee cherry extract in people with Effect of Drug, run by Auburn University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Effect of Drug
What is being tested?
Whole coffee cherry extract
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
323 participants
Where
1 siteUnited States
Study dates
1 Feb 2022to 29 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Auburn University

    Auburn, Alabama, 36849

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Effect of Drug
Being tested
Whole coffee cherry extract, Placebo
Keywords
coffee cherry, cognition, virtual study, internet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole coffee cherry extractDietary supplement

    Also called WCCE, CCE

    200mg WCCE

  • PlaceboDietary supplement

    Placebo for comparison to WCCE

Study groups in NCT04986956
Study groupRoleWhat they receive
PlaceboPlacebo comparatorThe placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products.
Receives: Dietary Supplement: Placebo
Whole coffee cherry extractActive comparatorWhole 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.
Receives: Dietary Supplement: Whole coffee cherry extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Behavioral Measures - Change in Go/NoGo Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  2. Behavioral Measures - Change in N-back Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  3. Behavioral Measures - Change in Face-Name Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  4. Behavioral Measures - Change in Stroop Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  5. Behavioral Measures - Change in Flanker Task Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  6. Behavioral Measures - Change in Symbol Search Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  7. Behavioral Measures - Change in Trail Making Reaction Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

  8. Behavioral Measures - Change in Face in the Crowd Time

    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.

    Measured: Collected at baseline (pre- and post-consumption) and then once weekly (pre-consumption) through the duration of the study (approximately 28 days)

Secondary outcomes (4)

  1. Daily Self-reported Sleep

    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.

    Measured: The question will be administered daily for the duration of the study (approximately 28 days)

  2. Weekly Self-reported Sleep Hygiene

    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.

    Measured: Questions are administered weekly for the duration of the study (approximately 28 days)

  3. Weekly Self-reported Mood

    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.

    Measured: The questionnaire is administered weekly for the duration of the study (approximately 28 days)

  4. Daily Self-reported Mood

    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).

    Measured: The question will be administered daily for the duration of the study (approximately 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start1 Feb 2022
  3. Primary completion31 Oct 2022
  4. Study completion29 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of two groups - study materials (whole coffee cherry extract (WCCE) or placebo).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986956
Sponsor's protocol ID
#21-219
Acronym
WCCE
Status last verified
Jan 2024
First submitted
27 Jul 2021
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao H, Ou J, Chen L, Zhang Y, Szkudelski T, Delmas D, Daglia M, Xiao J. Dietary polyphenols and type 2 diabetes: Human Study and Clinical Trial. Crit Rev Food Sci Nutr. 2019;59(20):3371-3379. doi: 10.1080/10408398.2018.1492900. Epub 2018 Nov 19.

    PubMed 29993262

  • Hurtado-Barroso S, Quifer-Rada P, Rinaldi de Alvarenga JF, Perez-Fernandez S, Tresserra-Rimbau A, Lamuela-Raventos RM. Changing to a Low-Polyphenol Diet Alters Vascular Biomarkers in Healthy Men after Only Two Weeks. Nutrients. 2018 Nov 14;10(11):1766. doi: 10.3390/nu10111766.

    PubMed 30441880

  • Mendonca RD, Carvalho NC, Martin-Moreno JM, Pimenta AM, Lopes ACS, Gea A, Martinez-Gonzalez MA, Bes-Rastrollo M. Total polyphenol intake, polyphenol subtypes and incidence of cardiovascular disease: The SUN cohort study. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):69-78. doi: 10.1016/j.numecd.2018.09.012. Epub 2018 Oct 4.

    PubMed 30459074

  • Schuster J, Mitchell ES. More than just caffeine: psychopharmacology of methylxanthine interactions with plant-derived phytochemicals. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:263-274. doi: 10.1016/j.pnpbp.2018.09.005. Epub 2018 Sep 10.

    PubMed 30213684

  • Sarubbo F, Moranta D, Pani G. Dietary polyphenols and neurogenesis: Molecular interactions and implication for brain ageing and cognition. Neurosci Biobehav Rev. 2018 Jul;90:456-470. doi: 10.1016/j.neubiorev.2018.05.011. Epub 2018 May 23.

    PubMed 29753753

  • Shukitt-Hale B, Miller MG, Chu YF, Lyle BJ, Joseph JA. Coffee, but not caffeine, has positive effects on cognition and psychomotor behavior in aging. Age (Dordr). 2013 Dec;35(6):2183-92. doi: 10.1007/s11357-012-9509-4. Epub 2013 Jan 24.

    PubMed 23344884

  • Whyte AR, Cheng N, Fromentin E, Williams CM. A Randomized, Double-Blinded, Placebo-Controlled Study to Compare the Safety and Efficacy of Low Dose Enhanced Wild Blueberry Powder and Wild Blueberry Extract (ThinkBlue) in Maintenance of Episodic and Working Memory in Older Adults. Nutrients. 2018 May 23;10(6):660. doi: 10.3390/nu10060660.

    PubMed 29882843

  • Robinson JL, Hunter JM, Reyes-Izquierdo T, Argumedo R, Brizuela-Bastien J, Keller R, Pietrzkowski ZJ. Cognitive short- and long-term effects of coffee cherry extract in older adults with mild cognitive decline. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2020 Nov;27(6):918-934. doi: 10.1080/13825585.2019.1702622. Epub 2019 Dec 12.

    PubMed 31829793

  • Robinson JL, Yanes JA, Reid MA, Murphy JE, Busler JN, Mumford PW, Young KC, Pietrzkowski ZJ, Nemzer BV, Hunter JM, Beck DT. Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults with Subjective Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study. Antioxidants (Basel). 2021 Jan 20;10(2):144. doi: 10.3390/antiox10020144.

    PubMed 33498314

  • Heimbach JT, Marone PA, Hunter JM, Nemzer BV, Stanley SM, Kennepohl E. Safety studies on products from whole coffee fruit. Food Chem Toxicol. 2010 Aug-Sep;48(8-9):2517-25. doi: 10.1016/j.fct.2010.06.025. Epub 2010 Jun 18.

    PubMed 20600539

  • Yashin A, Yashin Y, Wang JY, Nemzer B. Antioxidant and Antiradical Activity of Coffee. Antioxidants (Basel). 2013 Oct 15;2(4):230-45. doi: 10.3390/antiox2040230.

    PubMed 26784461

  • Reed, R.A., et al., Acute Low and Moderate Doses of a Caffeine-Free Polyphenol-Rich Coffeeberry Extract Improve Feelings of Alertness and Fatigue Resulting from the Performance of Fatiguing Cognitive Tasks. Journal of Cognitive Enhancement, 2018.

  • Reyes-Izquierdo T, Nemzer B, Shu C, Huynh L, Argumedo R, Keller R, Pietrzkowski Z. Modulatory effect of coffee fruit extract on plasma levels of brain-derived neurotrophic factor in healthy subjects. Br J Nutr. 2013 Aug 28;110(3):420-5. doi: 10.1017/S0007114512005338. Epub 2013 Jan 14.

    PubMed 23312069

  • Abdel-Aziz K, Larner AJ. Six-item cognitive impairment test (6CIT): pragmatic diagnostic accuracy study for dementia and MCI. Int Psychogeriatr. 2015 Jun;27(6):991-7. doi: 10.1017/S1041610214002932. Epub 2015 Jan 29.

    PubMed 25630996

Questions about this trial

What is this clinical trial studying?

A study testing Whole coffee cherry extract in people with Effect of Drug, run by Auburn University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986956, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024; AzTrials last refreshed its copy on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in