Effects of a Cocoa Shot on the Human Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Working Memory (% correct)
研究概览
简要总结
The Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine (and related chemicals such as theobromine) and flavonoids. Flavonoids are chemical found in plants and are most commonly associated with antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all naturally occurring and all potentially alter brain physiology. This study will evaluate changes in brain blood flow and cognition following the consumption of drinks with various combinations of the Primary Ingredients. Caffeine is likely to have peak effects within 1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4 hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an attempt to understand the differential effects of these compounds in chocolate drinks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consume 200-600 mg caffeine daily
- •Willing and capable of signing the informed consent
- •Willing to attend 4 testing sessions that will take 4-6 hours each AND will be at least 7 days apart
- •Willing to abstain from caffeine for 24 hours before each testing session
- •Willing to and able to have MRIs
排除标准
- •As determined from the medical screening session
- •active neurological dysfunction (such as a major Axis I psychopathology, Alzheimer's disease, Parkinson's disease, prior history of stroke, epilepsy, or serious central nervous system (CNS) trauma)
- •attention deficit hyperactivity disorder (ADHD)
- •migraines
- •hypertension
- •peripheral vascular disease
- •taking vasoactive medications (such as anti-hypertensive medications)
- •depression that has not been on a stable medical treatment for at least 4 weeks
- •Pregnancy
- •Color blindness
- •Allergy to chocolate, peanuts, tree nuts, egg, soy, mike, wheat
- •Individuals who are or potentially may be cognitively or psychologically impaired, or who otherwise have a limited capacity to provide consent
研究组 & 干预措施
low theobromine & low caffeine
Drink 1
干预措施: Low caffeine (Dietary Supplement)
low theobromine & low caffeine
Drink 1
干预措施: low theobromine (Dietary Supplement)
low theobromine & high caffeine
Drink 2
干预措施: High Caffeine (Dietary Supplement)
low theobromine & high caffeine
Drink 2
干预措施: low theobromine (Dietary Supplement)
high theobromine & low caffeine
Drink 3
干预措施: Low caffeine (Dietary Supplement)
high theobromine & low caffeine
Drink 3
干预措施: High theobromine (Dietary Supplement)
no theobromine & high caffeine
Drink 4
干预措施: High Caffeine (Dietary Supplement)
no theobromine & high caffeine
Drink 4
干预措施: No theobromine (Dietary Supplement)
结局指标
主要结局
Change in Working Memory (% correct)
时间窗: before, 1 hour and 3 hours post beverage
N-Back Task
Change in Mood (change in Likert scale score)
时间窗: before, 1 hour and 3 hours post beverage
Profile of Mood Status(POMS)
Change in Attention (% accuracy)
时间窗: before, 1 hour and 3 hours post beverage
Eriksen Flanker Task
Change in Response Time (milliseconds)
时间窗: before, 1 hour and 3 hours post beverage
Simple Response Time Task
Change in Short Term Memory (# correct)
时间窗: before, 1 hour and 3 hours post beverage
Hopkins Verbal Learning Task (HVLT)
Change in Executive Function (# correct)
时间窗: before, 1 hour and 3 hours post beverage
Stroop Task
次要结局
- % Change in Blood Pressure (mmHg)(before, 1 hour and 3 hours post beverage)
- % Change in Heart Rate (beats/minute)(before, 1 hour and 3 hours post beverage)
- % Change in Respiration (breaths/minute)(before, 1 hour and 3 hours post beverage)
- Change in Brain Blood Flow (ml/g/min)(1 hour and 3 hours post beverage)