Clinical trial NCT03812744: Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults
Official title: Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults: An fMRI Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Deficits
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Behavioral Measures - Change in Go/No-Go Reaction Time
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Behavioral Measures - Change in N-back Reaction Time
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Behavioral Measures - Change in Go/No-Go Accuracy
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Behavioral Measures - Change in N-back Accuracy
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Change in Concentration of Neurometabolites
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Change in Blood Levels of Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Blood Oxygen Level Dependent (BOLD) Changes
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Auburn University
name: Jennifer L Robinson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: