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

NCT ID: NCT05926050

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2022-08-10

Brief Summary

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.

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.

Conditions

Reaction Time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dietary supplement intervention

Participants were treated with 2 tablets containing extracts of American ginseng, bacopa monnieri and coffee fruit

Group Type: EXPERIMENTAL

Treatment (CopaPrime+ (USANA Health Sciences)

Intervention Type: DIETARY_SUPPLEMENT

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)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

CopaPrime+ (USANA Health Sciences)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Ski & Snowboard

UNKNOWN

Sponsor Role: collaborator

USANA Health Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Mark Levy

Director of Product Validation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Levy, PhD

Role: PRINCIPAL_INVESTIGATOR

USANA Health Sciences

Locations

US Ski and Snowboard Center of Excellence

Park City, Utah, United States

Countries

United States

Other Identifiers

202101CT

Identifier Type: -

Identifier Source: org_study_id