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Whole Coffee Cherry Study

NCT04986956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2024-01-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Whole coffee cherry extract

200mg WCCE

DIETARY_SUPPLEMENT

Placebo

Placebo for comparison to WCCE

Sponsors & Collaborators

  • VDF FutureCeuticals Inc.

    collaborator INDUSTRY

  • Auburn University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-10-31
Completion
2024-01-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04986956 on ClinicalTrials.gov