Skip to main content
OpenTrials
Completed

NCT Number: NCT03812744

Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults

This study was designed to characterize the changes in the brain and body associated with whole coffee cherry extract (WCCE). WCCE is a patented extract of whole coffee fruit (coffee berries) from coffea arabica. Whole coffee cherries are a source of naturally occurring nutrients. There are no known side effects or allergens associated with WCCE other than that which would be associated with a consuming typical cup of coffee.

Previous studies suggest that increases in serum concentrations of both serum total and exosomal brain-derived neurotrophic factors (BDNF) may represent one of the mechanisms responsible for improved cognitive function after acute WCCE administration. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. Furthermore, MCI is associated with reduced circulating BDNF. Due to earlier studies reporting the ability of WCCE to stimulate increases in circulating and exosomal BDNF, it has been postulated that WCCE may also acutely improve cognitive function (as measured using behavioral tasks and fMRI). The purpose of this study is to extend and elucidate the findings of previous investigations by examining the acute neurophysiological effects of WCCE using blood-oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) employing a double-blind, randomized crossover design to investigate the acute effects of a single dose of WCCE or placebo (silica oxide) on neuronal activity in older participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Memory Deficits Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complaints of memory, verified by an informant
  • 55 years of age or older

Exclusion criteria

  • MRI contraindications
  • Diagnosis of Alzheimer's Disease or suspected diagnosis at the time of visit by study personnel
  • Significant cerebrovascular disease
  • History of cardiovascular disease
  • Current or recently prescribed medication known to interfere with peripheral and/or cerebral blood flow or vascular function

Treatment and study plan

Whole coffee cherry extract (WCCE)

Drug

100mg WCCE

Placebo Oral Capsule [CEBOCAP]

Drug

Silica Oxide

Primary outcomes

  1. Behavioral Measures - Change in Go/No-Go Reaction Time

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Response/reaction time for each stimuli will be recorded in ms using E-Prime. Reaction times will be calculated for correct and incorrect trials separately.

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

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Response/reaction time for each stimuli will be recorded in ms using E-Prime. Reaction times will be calculated for correct and incorrect trials separately.

  3. Behavioral Measures - Change in Go/No-Go Accuracy

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Accuracy will be determined as the number of trials correct, and errors will be classified as errors of omission or commission.

  4. Behavioral Measures - Change in N-back Accuracy

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Accuracy will be determined as the number of trials correct.

  5. Change in Concentration of Neurometabolites

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Magnetic resonance spectroscopy (MRS) measurements pre/post ingestion. The following are measured: glutamate, glutamine, gamma-aminobutyric acid, N-acetylaspartate, choline, creatine, glutathione, myo-inositol, aspartate, taurine, and lactate. LCModel software performed automatic quantification of in vivo proton MR spectra by analyzing spectra as a linear combination of model spectra from sequence-specific simulations. Water-suppressed spectra were eddy current corrected and quantified using the unsuppressed water signal. Cramer-Rao lower bounds were used as a measure of fit with CRLB > 50% rejected from further analysis. Metabolite concentrations were CSF-corrected, and quantified (in ppm).

  6. Change in Blood Levels of Brain Derived Neurotrophic Factor (BDNF)

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Serum and exosomal BDNF concentrations

  7. Blood Oxygen Level Dependent (BOLD) Changes

    Time frame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

    Functional magnetic resonance imaging blood-oxygen-level-dependent signal changes across tasks, and during resting state

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults: An fMRI Investigation

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2019
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.