Dose Effect of a Plant Extract on Fatigue

NCT03870126 | Completed

• 1 other identifier: PEP-1807
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Physical performance

  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

  After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.

• Alertness

  After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.

• Effort

  After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.

• Quadriceps muscle pain

  After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.

Study Arms (4)

Flavored Beverage Mix 1

PLACEBO COMPARATOR

Flavored still beverage

Other: Flavored beverage

Flavored Beverage Mix 2

EXPERIMENTAL

Flavored still beverage with polyphenols, concentration 1

Other: Flavored beverage

Flavored Beverage Mix 3

EXPERIMENTAL

Flavored still beverage with polyphenols, concentration 2

Other: Flavored beverage

Flavored Beverage Mix 4

EXPERIMENTAL

Flavored still beverage with caffeine

Other: Flavored beverage

Interventions

Flavored beverage OTHER

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

Flavored Beverage Mix 1; Flavored Beverage Mix 2; Flavored Beverage Mix 3; Flavored Beverage Mix 4

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick J O'Connor, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 11, 2019
• Study Start: January 29, 2019
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Open access, upon request

Locations

US (1)