Clinical trial NCT03870126: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Subjective mental energy: Cognitive test battery
timeFrame: Baseline and 60 min post treatment
measure: Subjective mental energy: VAS for mental alertness
timeFrame: Baseline and 60 min post treatment
measure: Subjective mental energy: VAS for motivation
timeFrame: Baseline and 60 min post treatment
measure: Subjective mental energy: VAS for mental fatigue
timeFrame: Baseline and 60 min post treatment
measure: Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
timeFrame: Baseline and 60 min post treatment
measure: Subjective mental energy: VAS for mood
timeFrame: Baseline and 60 min post treatment
measure: Subjective mental energy: VAS for caffeine symptoms
timeFrame: Baseline and 60 min post treatment
Secondary outcomes:
measure: Physical performance
timeFrame: 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.
measure: Physical Fatigue
timeFrame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
measure: Alertness
timeFrame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
measure: Effort
timeFrame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
measure: Quadriceps muscle pain
timeFrame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Patrick J O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References: