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Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812744
Recruitment Status : Completed
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer L. Robinson, Ph.D., Auburn University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Memory Deficits Drug: Whole coffee cherry extract (WCCE) Drug: Placebo Oral Capsule [CEBOCAP] Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-site, randomized, placebo-controlled, cross-over, within-subjects design. Study sessions are no more than 72 hours apart. Visits included pre-post assessments following ingestion of either placebo or WCCE.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Investigators, participants, and the sponsor were all blind.
Primary Purpose: Basic Science
Official Title: Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults: An fMRI Investigation
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Arm Intervention/treatment
Experimental: WCCE Drug: Whole coffee cherry extract (WCCE)
100mg WCCE
Placebo Comparator: Placebo Drug: Placebo Oral Capsule [CEBOCAP]
Silica Oxide


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812744


Sponsors and Collaborators
Auburn University
Investigators
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Principal Investigator: Jennifer L Robinson, Ph.D. Auburn University
More Information
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Responsible Party: Jennifer L. Robinson, Ph.D., Associate Professor, Auburn University
ClinicalTrials.gov Identifier: NCT03812744    
Other Study ID Numbers: 16-391 MR 1610
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases