Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults

NCT ID: NCT03812744

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

WCCE

Group Type: EXPERIMENTAL

Whole coffee cherry extract (WCCE)

Intervention Type: DRUG

100mg WCCE

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Capsule [CEBOCAP]

Intervention Type: DRUG

Silica Oxide

Interventions

Whole coffee cherry extract (WCCE)

100mg WCCE

Intervention Type: DRUG

Placebo Oral Capsule [CEBOCAP]

Silica Oxide

Intervention Type: DRUG

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer L. Robinson, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer L Robinson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Other Identifiers

16-391 MR 1610

Identifier Type: -

Identifier Source: org_study_id