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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astaxanthin | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astaxanthin | Dietary Supplement | Manufactured by AstaReal Inc |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Time | How quickly the participant reacts to a stimulus. Expressed in millaseconds. The lower the number, the faster the participants reacted to the given stimulus. All test were conducted on an iPad using the cognitive software SOMANPT. | Pre supplementation and 4 weeks supplementation period. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Alabama | Florence | Alabama | 35632 | United States |
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Word of mouth at the University of North Alabama.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Astaxanthin: Manufactured by AstaReal Inc |
| FG001 | 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. Placebo: Manufactured by AstaReal Inc |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Astaxanthin: Manufactured by AstaReal Inc |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reaction Time | How quickly the participant reacts to a stimulus. Expressed in millaseconds. The lower the number, the faster the participants reacted to the given stimulus. All test were conducted on an iPad using the cognitive software SOMANPT. | Posted | Mean | Standard Deviation | milliseconds | Pre supplementation and 4 weeks supplementation period. |
|
Participants supplemented with astaxanthin for four weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Astaxanthin: Manufactured by AstaReal Inc |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hunter Waldman | University of North Alabama | 256.765.4996 | hswaldman@una.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2025 | Feb 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2024 | Jun 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| C005948 | astaxanthine |
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Groups will be randomized and parallel. They will not cross-over with each other.
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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.
| Placebo |
| Dietary Supplement |
Manufactured by AstaReal Inc |
|
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.
Placebo: Manufactured by AstaReal Inc
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. Placebo: Manufactured by AstaReal Inc | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001519 | Behavior |