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Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults

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Auburn University

Status

Completed

Conditions

Memory Deficits

Treatments

Drug: Whole coffee cherry extract (WCCE)
Drug: Placebo Oral Capsule [CEBOCAP]

Study type

Interventional

Funder types

Other

Identifiers

NCT03812744
16-391 MR 1610

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

8 participants in 2 patient groups, including a placebo group

WCCE
Experimental group
Treatment:
Drug: Whole coffee cherry extract (WCCE)
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo Oral Capsule [CEBOCAP]

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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