The Acute Effects of a Dietary Supplement on Cognitive Performance in Highly Trained Athletes.

The Acute Effects of a Dietary Supplement on Cognitive Performance in a Group of Highly Trained Athletes.

This study was designed to determine if a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit can enhance cognitive performance in a population of trained athletes.

Study Overview

• Status: Completed
• Conditions: Reaction Time
• Intervention / Treatment: Dietary supplement: Treatment (CopaPrime+ (USANA Health Sciences); Other: Placebo

Detailed Description

In this study, we hypothesized that consumption of a dietary supplement containing extracts of American ginseng, bacopa monnieri and coffee fruit will improve reaction time and short-term memory in a population of highly trained athletes.

In order to test this hypothesis, we will employ a randomized, double blind, placebo controlled, parallel arm study design. 40-50 subjects will be recruited and randomized in a 1:1 ratio to either of two interventions:

Placebo: consumption of the placebo tablet Treatment: consumption of the supplement (treatment) tablet

On the day of the study, subjects will perform a series of reaction time tasks specific to the upper (i.e., arms) and lower (i.e., legs) body. They will also be asked to perform the stroop test. At the conclusion of baseline testing, subjects will consume either the placebo or treatment tablet. One hour later, the subjects will repeat all reaction time tasks as well as the stroop test. Differences in reaction time, as well as the error rate within each reaction time or stroop test, will serve as the primary endpoint. The data will then be analyzed to determine if there is a difference in the before and after reaction times and error rates between subjects on treatment and those consuming the placebo tablets.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Park City, Utah, United States, 84060
      • US Ski and Snowboard Center of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provide a signed Informed Consent prior to screening for entry in the study
• Male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background
• Are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study
• Comprehensive Metabolic Panel results reported within normal laboratory reference ranges
• Have a Body Mass Index of ≤ 30
• Are fully able and willing to comply with the requirements of the study
• Are fully able and willing to keep scheduled appointments

Exclusion Criteria:

• Pregnant or attempting to become pregnant or lactating females.
• Chronic or acute use of prescription or over-the-counter medications that may interfere with absorption of the test supplement or confound results.
• Gastrointestinal conditions (e.g., inflammatory bowel disease, Crohn's disease, etc.) that may affect consumption of the treatment supplements.
• Significant acute or chronic illness or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study; insulin-dependent and orally controlled diabetics will also be excluded from the study.
• Scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all the necessary study visits.
• Individual's that have trouble swallowing pills.
• Individuals that have participated as a subject in any other clinical study within 30 days of the screening visit.
• A history of alcohol abuse or other substance abuse within the previous 2 years.
• Currently using tobacco products including chewing tobacco and cigarettes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement intervention; Participants were treated with 2 tablets containing extracts of American ginseng, bacopa monnieri and coffee fruit	Dietary supplement: Treatment (CopaPrime+ (USANA Health Sciences); Participants received and consumed 2 treatment tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained extracts of Bacopa monnieri (150 mg), Coffea arabica (50 mg), and Panax quinquefolius L. (50 mg); Other Names: CopaPrime+ (USANA Health Sciences)
Placebo Comparator: Placebo Treatment; Participants received 2 placebo tablets containing microcrystalline cellulose. The size, shape and appearance of the placebo tablet is identical to the treatment tablet.	Other: Placebo; Participants received and consumed 2 placebo tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained microcrystalline cellulose. The size, shape and appearance of the placebo tablet was identical to the treatment tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction time	Participants will perform a series of reaction time tasks prior to and after consumption of either the treatment or placebo tablets. Reaction times will be quantified and analyzed to determine if the intervention affected these measures.	One hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroop test	Participants are asked to identify the font color of a word (i.e., red, blue, green, yellow) by pressing a specific key on the keyboard when the word appears on a computer screen. In situation #1, the font color of the word matches the written word (congruent test). In situation #2, the font color does not match the written word (incongruent test).	One hour

Collaborators and Investigators

• Sponsor: USANA Health Sciences
• Collaborators: U.S. Ski & Snowboard
• Investigators: Principal Investigator: Mark Levy, PhD, USANA Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202101CT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No