Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04986956
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2021-07-27
Brief Title:
Whole Coffee Cherry Study
Sponsor:
Auburn University
Organization:
Auburn University
Study Overview
Official Title:
Longitudinal Study to Assess the Effects of Whole Coffee Cherry Extract WCCE
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WCCE
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 eg 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 NeurofactorTM 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 httpswwwmillisecondcom The cognitive assessment will be composed of tasks that broadly test working memory focus and attention Compliance checks will be administered daily via the participants 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 malesfemales 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None