Dose Effect of a Plant Extract on Fatigue

Study Overview
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Brief Summary
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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

Official Title
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Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue

Conditions
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Mental Energy, Physical Performance

Intervention / Treatment
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* Other: Flavored beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Flavored Beverage Mix 1<br>Flavored still beverage | Other: Flavored beverage<br>* Consume one beverage at the beginning of each visit of the cross-over sequence<br>|
| Experimental: Flavored Beverage Mix 2<br>Flavored still beverage with polyphenols, concentration 1 | Other: Flavored beverage<br>* Consume one beverage at the beginning of each visit of the cross-over sequence<br>|
| Experimental: Flavored Beverage Mix 3<br>Flavored still beverage with polyphenols, concentration 2 | Other: Flavored beverage<br>* Consume one beverage at the beginning of each visit of the cross-over sequence<br>|
| Experimental: Flavored Beverage Mix 4<br>Flavored still beverage with caffeine | Other: Flavored beverage<br>* Consume one beverage at the beginning of each visit of the cross-over sequence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective mental energy: Cognitive test battery | 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. | Baseline and 60 min post treatment | 
| Subjective mental energy: VAS for mental alertness | 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). | Baseline and 60 min post treatment | 
| Subjective mental energy: VAS for motivation | 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). | Baseline and 60 min post treatment | 
| Subjective mental energy: VAS for mental fatigue | 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). | Baseline and 60 min post treatment | 
| Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales) | 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). | Baseline and 60 min post treatment | 
| Subjective mental energy: VAS for mood | 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). | Baseline and 60 min post treatment | 
| Subjective mental energy: VAS for caffeine symptoms | 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). | Baseline and 60 min post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance | Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS. | 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. | 
| Physical Fatigue | Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue | After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise. | 
| Alertness | Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy | After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise. | 
| Effort | Subjective categorical scale, Borg Ratings of Perceived Exertion (RPE) measures perception of effort, score range 6-20. Higher score indicates greater effort. 17 or greater generally indicates maximal effort | After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise. | 
| Quadriceps muscle pain | Subjective categorical scale with ratio-like properties, scale 0-10 with open-ended option for ratings greater than but proportional to 10. Higher scores indicate greater perception of pain in the quadriceps | After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive, phytochemicals, caffeine, polyphenol, beverage, exercise, mental performance, physical performance, vigilance, vigor, energy, vitality, fatigue, sports performance, high-intensity intermittent exercise