Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460181
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-28
Brief Title:
Impact of Astaxanthin on Cognition in Recreationally Active Females
Sponsor:
University of North Alabama
Organization:
University of North Alabama
Study Overview
Official Title:
Impact of Astaxanthin on Cognition in Recreationally Active Females
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study is to examine the protentional that the antioxidant Astaxanthin has on mitigating cognitive decline following mental fatigue
Detailed 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 individuals 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 AXs 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 AXs 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 mgday 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 mgday 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
Astaxanthin AX is a naturally occurring antioxidant typically found in marine species such as algae salmon trout and shellfish AXs 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 AXs 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 mgday 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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None