Clinical trial NCT05926050: The Acute Effects of a Dietary Supplement on Cognitive Performance in Highly Trained Athletes.
Official title: The Acute Effects of a Dietary Supplement on Cognitive Performance in a Group of Highly Trained Athletes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reaction Time
Lead sponsor: USANA Health Sciences
Sponsor class: INDUSTRY
Collaborators: name: U.S. Ski & Snowboard
First posted: 2023-07-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind placebo controlled randomized clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reaction time
timeFrame: One hour
Secondary outcomes:
measure: Stroop test
timeFrame: One hour
Other outcomes:
Locations:
city: Park City
country: United States
facility: US Ski and Snowboard Center of Excellence
state: Utah
Study officials:
affiliation: USANA Health Sciences
name: Mark Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References: