Neurophysiological Effects of Whole Coffee Cherry Extract in Older Adults: An fMRI Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Behavioral Measures - Change in Go/No-Go Accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators, participants, and the sponsor were all blind.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Complaints of memory, verified by an informant
- •55 years of age or older
排除标准
- •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
研究组 & 干预措施
WCCE
干预措施: Whole coffee cherry extract (WCCE) (Drug)
Placebo
干预措施: Placebo Oral Capsule [CEBOCAP] (Drug)
结局指标
主要结局
Behavioral Measures - Change in Go/No-Go Accuracy
时间窗: 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.
Behavioral Measures - Change in N-back Reaction Time
时间窗: 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.
Behavioral Measures - Change in Go/No-Go Reaction Time
时间窗: 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.
Behavioral Measures - Change in N-back Accuracy
时间窗: 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.
Change in Concentration of Neurometabolites
时间窗: 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).
Change in Blood Levels of Brain Derived Neurotrophic Factor (BDNF)
时间窗: 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
Blood Oxygen Level Dependent (BOLD) Changes
时间窗: 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
次要结局
未报告次要终点
研究者
Jennifer L. Robinson, Ph.D.
Associate Professor
Auburn University