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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06460181
Other study ID # 2024-021
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 1, 2024
Est. completion date November 1, 2024

Study information

Verified date June 2024
Source University of North Alabama
Contact Gaven A Barker
Phone 678-699-3248
Email gbarker@una.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the protentional that the antioxidant Astaxanthin has on mitigating cognitive decline following mental fatigue.


Description:

Dietary supplements are used in all levels of sports to impact various areas of athletic performance. Prolonged physical activity or cognitive engagement, which is a part of the competition, can increase mental fatigue (MF) such that the athlete begins to experience impaired decision-making skills and slower reaction times, resulting in a less-than-optimal athlete by the end of the competition. Thus, identifying interventions that may preserve an individual's ability to perform following a state of MF would interest individuals often engaged in competition or training. Astaxanthin (AX) is a naturally occurring antioxidant typically found in marine species such as algae, salmon, trout, and shellfish. AX's unique structure may mitigate inflammation. Cognitively, AX can cross the blood-brain barrier to help support the mitochondria when metabolic or cognitive demands are increased. While there have been promising results in elderly individuals of AX's ability to mitigate reductions in cognitive performance when fatigued. However, investigations in younger, more active individuals are warranted. Therefore, the purpose of this study to examine the impact of four weeks of AX supplementation at 12 mg/day on various markers of cognitive performance following a mental fatiguing protocol in recreationally active females. The cognitive methods are adapted from another previous study titled, "No Benefit of Ingesting a Low-Dose Ketone Monoester Supplement on Markers of Cognitive Performance in Females" (IRB#: 2023-009). This study is a double-blind between design. Supplementation will last four weeks with each subject will consume either 12 mg/day of AX or a matched placebo. The participants will report to the lab for four separate trials. There will be two cognitive trials before and after supplementation. A 4 week supplementation period will occur after trials 1 & 2, followed by a repeat of these sessions for post-testing. We hypothesize that AX will mitigate cognitive detriments following mental fatigue. The significance of these results may extend to female athletes looking to enhance performance by protecting cognitive ability from declining after fatigue. Cognitive Protocol: Participants will use software called SOMA NPT to complete a series of validated cognitive tasks that test different aspects of cognition. The cognitive battery of test that will be used includes a Psychomotor Vigilance Test (PVT; 5 min), Task Switching (3 min), and Incongruent Flaker (3 min). The task that will be used to induce mental fatigue is a Time-Loaded-Dual-Back task (TLDB; 15 min). A control video titled World Class Trains (15 min) has been validated to produce no emotional response. Each subject will complete a trial with the mental fatigue protocol and a control before supplementation. Lipid Panel: A lipid panel to asses participants cholesterol and glucose levels will be taken both pre and post supplementation by using a capillary finger prick.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: - The participant population will be healthy, recreationally active females between the ages of 18-39 without any medical conditions. To be deemed recreationally active, they must meet the World Health Organization minimum activity guidelines of completing at least 150 to 300 min moderate-intensity activity or 75-150 min of vigorous-intensity activity a week, plus muscle-strengthening activities 2 or more days a week. - Adult females with a stable body weight (± 5 lbs.) for 2 months - Adult females with a normal menstrual cycle - Adult females not on a low-carb, high-fat diet or intermittent fasting - Adult females who are not pregnant of actively attempting to become pregnant Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Astaxanthin
Manufactured by AstaReal Inc
Placebo
Manufactured by AstaReal Inc

Locations

Country Name City State
United States University of North Alabama Florence Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of North Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reaction time How quickly the participant reacts to a stimulus. Expressed in millaseconds. Pre supplementation and post 4-week supplementation period.
Primary Speed Speed at which responses are given. Pre supplementation and post 4-week supplementation period.
Primary Responses Correct per Second Accuracy of responses over time. Pre supplementation and post 4-week supplementation period.
Primary Mental Fatigue Assessed using a 180mm visual analog scale. 0mm = no mental fatigue, 180mm = highest possible mental fatigue. Pre supplementation and post 4-week supplementation period.
Secondary Lipid Panel Cholesterol, lipid, and glucose levels. Tested using blood from the capillaries of the fingers Pre and post
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