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

NCT05926050 | Completed

• 1 other identifier: 202101CT
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Reaction Time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stroop test

  One hour

Study Arms (2)

Dietary supplement intervention

EXPERIMENTAL

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

Dietary Supplement: Treatment (CopaPrime+ (USANA Health Sciences)

Placebo Treatment

PLACEBO COMPARATOR

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

Interventions

Treatment (CopaPrime+ (USANA Health Sciences) 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)

Also known as: CopaPrime+ (USANA Health Sciences)

Dietary supplement intervention

Placebo 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.

Placebo Treatment

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• USANA Health Sciences: lead
• U.S. Ski & Snowboard: collaborator

Study Sites (1)

US Ski and Snowboard Center of Excellence

Park City, Utah, 84060, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Mark Levy, PhD

  USANA Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Product Validation

Model Details: Double-blind placebo controlled randomized clinical trial.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 3, 2023
• Study Start: September 8, 2021
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

US (1)