Dose Effect of a Plant Extract on Fatigue

NCT ID: NCT03870126

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2019-12-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Flavored Beverage Mix 1

Flavored still beverage

Group Type: PLACEBO_COMPARATOR

Flavored beverage

Intervention Type: OTHER

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

Flavored Beverage Mix 2

Flavored still beverage with polyphenols, concentration 1

Group Type: EXPERIMENTAL

Flavored beverage

Intervention Type: OTHER

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

Flavored Beverage Mix 3

Flavored still beverage with polyphenols, concentration 2

Group Type: EXPERIMENTAL

Flavored beverage

Intervention Type: OTHER

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

Flavored Beverage Mix 4

Flavored still beverage with caffeine

Group Type: EXPERIMENTAL

Flavored beverage

Intervention Type: OTHER

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

Interventions

Flavored beverage

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J O'Connor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

University of Georgia

Athens, Georgia, United States

Countries

United States

Other Identifiers

PEP-1807

Identifier Type: -

Identifier Source: org_study_id