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Dose Effect of a Plant Extract on Fatigue

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03870126
Enrollment
28
Registered
2019-03-11
Start date
2019-01-29
Completion date
2019-12-06
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Energy, Physical Performance

Keywords

cognitive, phytochemicals, caffeine, polyphenol, beverage, exercise, mental performance, physical performance, vigilance, vigor, energy, vitality, fatigue, sports performance, high-intensity intermittent exercise

Brief summary

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

Interventions

OTHERFlavored beverage

Consume one beverage at the beginning of each visit of the cross-over sequence

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective mental energy: VAS for caffeine symptomsBaseline and 60 min post treatmentChanges 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: VAS for mental alertnessBaseline and 60 min post treatmentChanges 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 energy: VAS for motivationBaseline and 60 min post treatmentChanges 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 fatigueBaseline and 60 min post treatmentChanges 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 and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)Baseline and 60 min post treatmentChanges 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 moodBaseline and 60 min post treatmentChanges 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).
Subjective mental energy: Cognitive test batteryBaseline and 60 min post treatmentChanges 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.

Secondary

MeasureTime frameDescription
Physical FatigueAfter each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
AlertnessAfter each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
EffortAfter each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.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
Quadriceps muscle painAfter each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.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
Physical performanceDuring 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.Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026