Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Subjective mental energy: VAS for caffeine symptoms
研究概览
简要总结
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-49 years of age
- •Self-report of good health
- •Physical activity requirement: Recreationally active (exercise ≥3 times per week for >30 minutes per session; both cyclists and non-cyclists may enroll)
排除标准
- •Under the care of a physician
- •Visual impairment that cannot be corrected with glasses or contact lenses
- •Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
- •Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or >50% incorrect responses)
- •Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
- •Pregnant/lactating
- •Current smoker
- •Report illegal drug use
- •Report hypersensitivity to caffeine
- •Food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products)
- •Current use of dietary supplements, or prescription medication except for oral contraceptives
- •Unwillingness to abstain from over the counter medications (e.g. NSAIDS, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study
- •Unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days.
- •Participation in another clinical trial within the past 30 days or participation in another PepsiCo trial in the past 6 months
结局指标
主要结局
Subjective mental energy: VAS for caffeine symptoms
时间窗: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. Caffeine symptoms are measured on paper using 8 Visual Analog Scales (VAS) with score range 0-100 (from not at all to extremely).
Subjective mental energy: Cognitive test battery
时间窗: Baseline and 60 min post treatment
Changes in subjective measures of mental alertness and mental fatigue through computer administered cognitive test battery domains of short-term memory, attention and mood. Tasks are word presentation, word recognition, picture presentation, picture recognition, Cognitive Demand Battery (CDB) serial 3 and serial 7 subtraction, and Bakan task/Rapid Visual Information Processing (RVIP). Performance measures: % correct, % errors and response time in milliseconds.
Subjective mental energy: VAS for motivation
时间窗: Baseline and 60 min post treatment
Changes in subjective ratings of motivation following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for motivation has the score range 0-100 (from not at all to extremely).
Subjective mental energy: VAS for mental fatigue
时间窗: Baseline and 60 min post treatment
Changes in subjective ratings of fatigue following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for fatigue has the score range 0-100 (from not at all to extremely).
Subjective mental energy: VAS for mental alertness
时间窗: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for mental alertness has the score range 0-100 (from not at all to extremely).
Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
时间窗: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. Mental and Physical State and Trait Energy and Fatigue Scales (EFS State Scales) consist of 12 VAS items to measure intensity of current feeling of physical energy and fatigue and mental energy and fatigue (3 sub-scales each). Score range: The 3 items from each sub-scale are summed and scores for each sub-scale range from 0-300 (none to strongest).
Subjective mental energy: VAS for mood
时间窗: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. The Bond-Lader test uses 16 Visual Analog Scales (VAS) to measure different aspects of mood, with score range 0-100 for each scale (from absence of feeling to presence of feeling).
次要结局
- Physical Fatigue(After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.)
- Alertness(After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.)
- Effort(After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.)
- Physical performance(During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.)
- Quadriceps muscle pain(After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.)