- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460181
Impact of Astaxanthin on Cognition in Recreationally Active Females
Astaxanthin Supplementation Preserves Cognitive Markers of Executive Function Following Mental Fatigue in Females
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Alabama
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Florence, Alabama, United States, 35632
- University of North Alabama
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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.
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Manufactured by AstaReal Inc
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Placebo Comparator: 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.
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Manufactured by AstaReal Inc
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reaction Time
Time Frame: Pre supplementation and 4 weeks supplementation period.
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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.
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Pre supplementation and 4 weeks supplementation period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid Panel
Time Frame: Pre and post
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Cholesterol, lipid, and glucose levels.
Tested using blood from the capillaries of the fingers
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Pre and post
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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