Whole Coffee Cherry Study

NCT04986956 | Completed

• 1 other identifier: #21-219
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Keywords

coffee cherry; cognition; virtual study; internet

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (4)

• Daily Self-reported Sleep

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

• Weekly Self-reported Sleep Hygiene

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

• Weekly Self-reported Mood

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

• Daily Self-reported Mood

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

Other Outcomes (1)

• Compliance

  Daily for the duration of the study (approximately 28 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products.

Dietary Supplement: Placebo

Whole coffee cherry extract

ACTIVE COMPARATOR

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

Interventions

Whole coffee cherry extract DIETARY_SUPPLEMENT

200mg WCCE

Also known as: WCCE, CCE

Whole coffee cherry extract

Placebo DIETARY_SUPPLEMENT

Placebo for comparison to WCCE

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Auburn University: lead
• VDF FutureCeuticals Inc.: collaborator

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (14)

• 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.

  PMID: 29993262 BACKGROUND

• 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.

  PMID: 30441880 BACKGROUND

• 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.

  PMID: 30459074 BACKGROUND

• 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.

  PMID: 30213684 BACKGROUND

• 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.

  PMID: 29753753 BACKGROUND

• 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.

  PMID: 23344884 BACKGROUND

• 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.

  PMID: 29882843 BACKGROUND

• 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.

  PMID: 31829793 BACKGROUND

• 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.

  PMID: 33498314 BACKGROUND

• 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.

  PMID: 20600539 BACKGROUND

• 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.

  PMID: 26784461 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23312069 BACKGROUND

• 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.

  PMID: 25630996 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding information will be held by the study sponsor, VDF FutureCeuticals, Inc. The study will be conducted in a double-blind fashion such that both the investigators and the participants are unaware of their assignment. Unblinding will only occur once the study has been completed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two groups - study materials (whole coffee cherry extract (WCCE) or placebo).

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: February 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: January 29, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)