Whole Coffee Cherry Study

NCT ID: NCT04986956

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-01-29

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.

Conditions

Effect of Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo for comparison to WCCE

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.

Group Type: ACTIVE_COMPARATOR

Whole coffee cherry extract

Intervention Type: DIETARY_SUPPLEMENT

200mg WCCE

Interventions

Whole coffee cherry extract

200mg WCCE

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo for comparison to WCCE

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

WCCE; CCE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VDF FutureCeuticals Inc.

INDUSTRY

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer L. Robinson, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Auburn University

Auburn, Alabama, United States

Countries

United States

References

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Other Identifiers

#21-219

Identifier Type: -

Identifier Source: org_study_id