Clinical trial NCT06460181: Impact of Astaxanthin on Cognition in Recreationally Active Females
Official title: Impact of Astaxanthin on Cognition in Recreationally Active Females
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Mental Fatigue
Lead sponsor: University of North Alabama
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Groups will be randomized and parallel. They will not cross-over with each other.
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Reaction time
timeFrame: Pre supplementation and post 4-week supplementation period.
measure: Speed
timeFrame: Pre supplementation and post 4-week supplementation period.
measure: Responses Correct per Second
timeFrame: Pre supplementation and post 4-week supplementation period.
measure: Mental Fatigue
timeFrame: Pre supplementation and post 4-week supplementation period.
Secondary outcomes:
measure: Lipid Panel
timeFrame: Pre and post
Other outcomes:
Locations:
city: Florence
country: United States
facility: University of North Alabama
state: Alabama
Study officials:
References: