- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03812744
Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults
Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults: An fMRI Investigation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Silica Oxide
|
Experimental: WCCE
|
100mg WCCE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
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.
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
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).
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
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
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
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.
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
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.
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
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
|
Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer L Robinson, Ph.D., Auburn University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-391 MR 1610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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