Dose Effect of a Plant Extract on Fatigue

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

Study Overview

• Status: Completed
• Conditions: Mental Energy; Physical Performance
• Intervention / Treatment: Other: Flavored beverage

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Patrick J O'Connor, PhD, University of Georgia

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; exercise; physical performance; caffeine; energy; beverage; cognitive; polyphenol; mental performance; phytochemicals; vigilance; vigor; vitality; sports performance; high-intensity intermittent exercise
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: PEP-1807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be kept securely at U. Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu)
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Open access, upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No