Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults

NCT03812744 | Completed

• 1 other identifier: 16-391 MR 1610
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Memory Deficits

Outcome Measures

Primary Outcomes (7)

• Behavioral Measures - Change in Go/No-Go Reaction Time

  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

  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 Go/No-Go Accuracy

  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

  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

  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)

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

  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)

• Blood Oxygen Level Dependent (BOLD) Changes

  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)

Study Arms (2)

WCCE

EXPERIMENTAL

Drug: Whole coffee cherry extract (WCCE)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Capsule [CEBOCAP]

Interventions

Whole coffee cherry extract (WCCE) DRUG

100mg WCCE

WCCE

Placebo Oral Capsule [CEBOCAP] DRUG

Silica Oxide

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer L Robinson, Ph.D.

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, participants, and the sponsor were all blind.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 23, 2019
• Study Start: October 1, 2016
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01