Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-30 @ 1:29 AM
Study NCT ID:
NCT05926050
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effects of a Dietary Supplement on Cognitive Performance in Highly Trained Athletes.
Sponsor:
USANA Health Sciences
Organization:
Study Overview
Official Title:
The Acute Effects of a Dietary Supplement on Cognitive Performance in a Group of Highly Trained Athletes.
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: