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OpenTrials
Completed

NCT Number: NCT03870126

Dose Effect of a Plant Extract on Fatigue

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

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Key information

Conditions

Mental Energy Behavior Fatigue Motor Activity Pathological Conditions, Signs and Symptoms Physical Performance Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia

Athens, Georgia, 30602, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flavored beverage

Other

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

Primary outcomes

  1. Subjective mental energy: Cognitive test battery

    Time frame: 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.

  2. Subjective mental energy: VAS for mental alertness

    Time frame: 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).

  3. Subjective mental energy: VAS for motivation

    Time frame: 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).

  4. Subjective mental energy: VAS for mental fatigue

    Time frame: 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).

  5. Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)

    Time frame: 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).

  6. Subjective mental energy: VAS for mood

    Time frame: 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).

  7. Subjective mental energy: VAS for caffeine symptoms

    Time frame: 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).

Secondary outcomes

  1. Physical performance

    Time frame: 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.

    Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.

  2. Physical Fatigue

    Time frame: After 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

  3. Alertness

    Time frame: After 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

  4. Effort

    Time frame: After 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

  5. Quadriceps muscle pain

    Time frame: After 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

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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