Back to resultsDose Effect of a Plant Extract on Fatigue
Primary Purpose
Mental Energy, Physical Performance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flavored beverage
Sponsored by
About this trial
This is an interventional basic science trial for Mental Energy focused on measuring cognitive, phytochemicals, caffeine, polyphenol, beverage, exercise, mental performance, physical performance, vigilance, vigor, energy, vitality, fatigue, sports performance, high-intensity intermittent exercise
Eligibility Criteria
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
Sites / Locations
- University of Georgia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Flavored Beverage Mix 1
Flavored Beverage Mix 2
Flavored Beverage Mix 3
Flavored Beverage Mix 4
Arm Description
Flavored still beverage
Flavored still beverage with polyphenols, concentration 1
Flavored still beverage with polyphenols, concentration 2
Flavored still beverage with caffeine
Outcomes
Primary Outcome Measures
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.
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
Physical performance
Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
Physical Fatigue
Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
Alertness
Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03870126
Brief Title
Dose Effect of a Plant Extract on Fatigue
Official Title
Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PepsiCo Global R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flavored Beverage Mix 1
Arm Type
Placebo Comparator
Arm Description
Flavored still beverage
Arm Title
Flavored Beverage Mix 2
Arm Type
Experimental
Arm Description
Flavored still beverage with polyphenols, concentration 1
Arm Title
Flavored Beverage Mix 3
Arm Type
Experimental
Arm Description
Flavored still beverage with polyphenols, concentration 2
Arm Title
Flavored Beverage Mix 4
Arm Type
Experimental
Arm Description
Flavored still beverage with caffeine
Intervention Type
Other
Intervention Name(s)
Flavored beverage
Intervention Description
Consume one beverage at the beginning of each visit of the cross-over sequence
Primary Outcome Measure Information:
Title
Subjective mental energy: Cognitive test battery
Description
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.
Time Frame
Baseline and 60 min post treatment
Title
Subjective mental energy: VAS for mental alertness
Description
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).
Time Frame
Baseline and 60 min post treatment
Title
Subjective mental energy: VAS for motivation
Description
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).
Time Frame
Baseline and 60 min post treatment
Title
Subjective mental energy: VAS for mental fatigue
Description
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).
Time Frame
Baseline and 60 min post treatment
Title
Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
Description
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).
Time Frame
Baseline and 60 min post treatment
Title
Subjective mental energy: VAS for mood
Description
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).
Time Frame
Baseline and 60 min post treatment
Title
Subjective mental energy: VAS for caffeine symptoms
Description
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).
Time Frame
Baseline and 60 min post treatment
Secondary Outcome Measure Information:
Title
Physical performance
Description
Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
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.
Title
Physical Fatigue
Description
Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
Time Frame
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Title
Alertness
Description
Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
Time Frame
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Title
Effort
Description
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
Time Frame
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Title
Quadriceps muscle pain
Description
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
Time Frame
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J O'Connor, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Dose Effect of a Plant Extract on Fatigue
We'll reach out to this number within 24 hrs