Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) on Brain Executive Function in Student Athletes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma
研究概览
简要总结
The goal of this study is to determine the impact of long chain omega-3 PUFA (Polyunsaturated fatty acids) supplementation on executive function in collegiate athletes in a randomized, double-blind, placebo-controlled trial
详细描述
The main objective of this study is to determine the effect of daily oral intake of a fish oil capsule enriched in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on brain EF (Executive Function) and blood-based biomarkers among male collegiate baseball student athletes over the course of an academic school year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
The capsules are of nearly identical color rendering them indistinguishable in appearance
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Wake Forest University National Collegiate Athletic Association (NCAA) Division I baseball male student athletes cleared to participate in university athletics as determined by the team physician
- •Age >/=18 years
排除标准
- •Unwillingness to consume a daily dietary supplement over the course of the study
- •Allergy to dietary supplement components
- •Lipid-lowering medication use
研究组 & 干预措施
safflower oil
participants will be asked to consume a daily (5 days per week) dietary supplement containing a placebo oil product (safflower oil) encapsulated in soft gel capsules.
干预措施: Safflower Oil (Dietary Supplement)
fish oil
participants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules.
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma
时间窗: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate plasma for EPA fatty acid analysis
Stop-Signal Test
时间窗: Baseline, Day 1
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed. Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Circulating levels of fatty acids - DHA in plasma
时间窗: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate plasma for DHA fatty acid analysis
Wisconsin Card Sort Test
时间窗: Baseline, Day 1
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility. The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
Barkley Deficits in Executive Functioning Scale (BDEFS)
时间窗: visit #2 (~6-8 weeks after baseline)
Evaluate dimensions of adult executive functioning in daily life - self administered - Items are answered on a 4-point scale ranging from "1= Never or rarely" to " 4 = Very often"; α's range from 0.91 to 0.96. Higher scores are interpreted as indicating greater deficits in EF - The Barkley Deficits in Executive Functioning Scale is an 89 item self-report measure of executive functioning.
Circulating levels of fatty acids - EPA on red blood cells
时间窗: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate red blood cells for EPA fatty acid analysis
Stroop Test
时间窗: Baseline, Day 1
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning). Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Circulating levels of fatty acids - DHA (docosahexaenoic acid) on Red blood cells
时间窗: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate red blood cells for DHA fatty acid analysis
Trail Making Test
时间窗: Baseline, Day 1
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Digit Span
时间窗: Baseline, Day 1
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Stroop Test
时间窗: visit #2 (~6-8 weeks after baseline)
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning). Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Trail Making Test
时间窗: visit #2 (~6-8 weeks after baseline)
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Stop-Signal Test
时间窗: visit #2 (~6-8 weeks after baseline)
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed. Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Digit Span
时间窗: visit #2 (~6-8 weeks after baseline)
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Wisconsin Card Sort Test
时间窗: visit #2 (~6-8 weeks after baseline)
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility. The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
次要结局
- Capsule consumption compliance(Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months))
- Weight(Visits 1 to 5, from baseline up to 9 months)
- Waist circumference(Visits 1 to 5, from baseline up to 9 months)
- Inflammatory and/or injury biomarkers (e.g., isoprostanes)(Visits 1 to 5, from baseline up to 9 months)
- Levels of inflammatory and/or injury biomarkers (TNF) (Tumor necrosis factor)(Visits 1 to 5, from baseline up to 9 months)
- Levels of inflammatory and/or injury biomarkers (CRP) (C-reactive protein)(Visits 1 to 5, from baseline up to 9 months)
- Depression, Anxiety and Stress Scale (DASS)(Visits 1 to 5, from baseline up to 9 months)
- Sleep patterns(4 Visits during 9 months (approximately 6-8 week intervals))
- Heart rate variability(From baseline up to 9 months)
- Heart rate(From baseline up to 9 months)
- Respiratory rate(From baseline up to 9 months)
- Barkley Deficits in Executive Functioning Scale (BDEFS)(From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months))
- BMI(Visits 1 to 5, from baseline up to 9 months)
- Hip circumferences(Visits 1 to 5, from baseline up to 9 months)
- Levels of inflammatory and/or injury biomarkers (creatinine kinase)(Visits 1 to 5, from baseline up to 9 months)
- Levels of Inflammatory and/or injury biomarkers (IGF) (Insulin-like growth factor 1)(Visits 1 to 5, from baseline up to 9 months)
- Trail Making Test(From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months))
- Levels of inflammatory and/or injury biomarkers (ROS) (Reactive oxygen species)(Visits 1 to 5, from baseline up to 9 months)
- Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin)(Post study - 9 months)
- Stop-Signal Test(From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months))
- Stroop Test(From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months))
- Wisconsin Card Sort Test(From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months))
- Reaction time assessment(weekly intervals for 9 months of study)
- Digit Span(From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months))