Impact of Astaxanthin on Cognition in Recreationally Active Females

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-11-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mental Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Groups will be randomized and parallel. They will not cross-over with each other.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants will supplement with either AX or a matched placebo. The dosage of AX (12 mg/day) is FDA approved and will be administered orally by one soft gel capsule. The treatments will be blinded to the participants and the investigator. Treatments will be sorted be an independent party not associated with data collection or analysis.

Study Groups

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Astaxanthin

Astaxanthin will be administered in a dosage of 12 mg/day orally by one soft gel capsule per day. the capsule consist of natural Astaxanthin and olive oil.

Group Type ACTIVE_COMPARATOR

Astaxanthin

Intervention Type DIETARY_SUPPLEMENT

Manufactured by AstaReal Inc

Placebo

The placebo will be administered orally by one soft gel capsule per day. The placebo contains olive oil and is color, order, and taste matched to the Astaxanthin soft gels.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Manufactured by AstaReal Inc

Interventions

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Astaxanthin

Manufactured by AstaReal Inc

Intervention Type DIETARY_SUPPLEMENT

Placebo

Manufactured by AstaReal Inc

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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