Dose Effect of a Plant Extract on Fatigue

PepsiCo

Status: Completed

Conditions: Physical Performance; Mental Energy

Treatments: Other: Flavored beverage

Study type: Interventional

Funder types: Industry

Identifiers

NCT03870126

PEP-1807

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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28 participants in 4 patient groups, including a placebo group

Flavored Beverage Mix 1

Placebo Comparator group

Description:

Flavored still beverage

Treatment:

Other: Flavored beverage

Flavored Beverage Mix 2

Experimental group

Description:

Flavored still beverage with polyphenols, concentration 1

Treatment:

Other: Flavored beverage

Flavored Beverage Mix 3

Experimental group

Description:

Flavored still beverage with polyphenols, concentration 2

Treatment:

Other: Flavored beverage

Flavored Beverage Mix 4

Experimental group

Description:

Flavored still beverage with caffeine

Treatment:

Other: Flavored beverage