跳至主要内容
临床试验/NCT06460181
NCT06460181已完成4 期

Astaxanthin Supplementation Preserves Cognitive Markers of Executive Function Following Mental Fatigue in Females

University of North Alabama2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Reaction time

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Placebo (Dietary Supplement)

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.

干预措施: Astaxanthin (Dietary Supplement)

结局指标

主要结局

Reaction time

时间窗: Pre supplementation and post 4-week supplementation period.

How quickly the participant reacts to a stimulus. Expressed in millaseconds.

Responses Correct per Second

时间窗: Pre supplementation and post 4-week supplementation period.

Accuracy of responses over time.

Speed

时间窗: Pre supplementation and post 4-week supplementation period.

Speed at which responses are given.

Mental Fatigue

时间窗: Pre supplementation and post 4-week supplementation period.

Assessed using a 180mm visual analog scale. 0mm = no mental fatigue, 180mm = highest possible mental fatigue.

次要结局

  • Lipid Panel(Pre and post)

研究者

发起方
University of North Alabama
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验