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Sponsor unable to send smaller necessary capsules
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fish oil | Active Comparator | participants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules. |
|
| safflower oil | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Barkley Deficits in Executive Functioning Scale (BDEFS) | 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. | visit #2 (~6-8 weeks after baseline) |
| Stroop Test | 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". | visit #2 (~6-8 weeks after baseline) |
| Stroop Test | 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". | Baseline, Day 1 |
| Trail Making Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Capsule consumption compliance | Percentage capsules taken | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaheh Rahbar, PhD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18789910 | Background | Innis SM. Dietary omega 3 fatty acids and the developing brain. Brain Res. 2008 Oct 27;1237:35-43. doi: 10.1016/j.brainres.2008.08.078. Epub 2008 Sep 9. | |
| 20130094 | Background | McNamara RK, Able J, Jandacek R, Rider T, Tso P, Eliassen JC, Alfieri D, Weber W, Jarvis K, DelBello MP, Strakowski SM, Adler CM. Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Am J Clin Nutr. 2010 Apr;91(4):1060-7. doi: 10.3945/ajcn.2009.28549. Epub 2010 Feb 3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2020 | Mar 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D015118 | Eicosapentaenoic Acid |
| D004281 | Docosahexaenoic Acids |
| D012450 | Safflower Oil |
| D005229 | Fatty Acids, Monounsaturated |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
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randomized, double-blind, placebo-controlled, two-arm intervention study
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The capsules are of nearly identical color rendering them indistinguishable in appearance
| Safflower Oil | Dietary Supplement | Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week |
|
|
| visit #2 (~6-8 weeks after baseline) |
| Trail Making Test | 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. | Baseline, Day 1 |
| Stop-Signal Test | 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 | visit #2 (~6-8 weeks after baseline) |
| Stop-Signal Test | 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 | Baseline, Day 1 |
| Digit Span | 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. | visit #2 (~6-8 weeks after baseline) |
| Digit Span | 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. | Baseline, Day 1 |
| Wisconsin Card Sort Test | 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. | visit #2 (~6-8 weeks after baseline) |
| Wisconsin Card Sort Test | 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. | Baseline, Day 1 |
| Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma | centrifuged to isolate plasma for EPA fatty acid analysis | visit #2 (~6-8 weeks after baseline) |
| Circulating levels of fatty acids - EPA on red blood cells | centrifuged to isolate red blood cells for EPA fatty acid analysis | visit #2 (~6-8 weeks after baseline) |
| Circulating levels of fatty acids - DHA (docosahexaenoic acid) on Red blood cells | centrifuged to isolate red blood cells for DHA fatty acid analysis | visit #2 (~6-8 weeks after baseline) |
| Circulating levels of fatty acids - DHA in plasma | centrifuged to isolate plasma for DHA fatty acid analysis | visit #2 (~6-8 weeks after baseline) |
| BMI | Visits 1 to 5, from baseline up to 9 months |
| Waist circumference | Visits 1 to 5, from baseline up to 9 months |
| Hip circumferences | Visits 1 to 5, from baseline up to 9 months |
| Depression, Anxiety and Stress Scale (DASS) | Designed to measure the negative emotional states of depression, anxiety and stress - It consists of three 14-item subscales with each item scored on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Total scores are calculated by summing the items on each subscale, giving a score range of 0-42 on each subscale. Scores above 20, 14 and 25 on the depression, anxiety and stress subscales respectively are indicative of severe levels. Higher scores denotes worse outcomes. | Visits 1 to 5, from baseline up to 9 months |
| Inflammatory and/or injury biomarkers (e.g., isoprostanes) | quantify plasma levels of inflammatory biomarker assays | 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 (ROS) (Reactive oxygen species) | quantify plasma levels of inflammatory biomarker assays | Visits 1 to 5, from baseline up to 9 months |
| Levels of Inflammatory and/or injury biomarkers (IGF) (Insulin-like growth factor 1) | quantify plasma levels of inflammatory biomarker assays | Visits 1 to 5, from baseline up to 9 months |
| Levels of inflammatory and/or injury biomarkers (TNF) (Tumor necrosis factor) | quantify plasma levels of inflammatory biomarker assays | Visits 1 to 5, from baseline up to 9 months |
| Levels of inflammatory and/or injury biomarkers (CRP) (C-reactive protein) | quantify plasma levels of inflammatory biomarker assays | Visits 1 to 5, from baseline up to 9 months |
| Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin) | quantify plasma levels of inflammatory biomarker assays | Post study - 9 months |
| Sleep patterns | Time spent in each sleep stage: Light, REM, Slow Wave (Deep), and Awake. | 4 Visits during 9 months (approximately 6-8 week intervals) |
| Reaction time assessment | Baseball performance, assessed by reaction time assessment using the DynaVision system | weekly intervals for 9 months of study |
| 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) | 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. | From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months) |
| Stroop Test | 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". | From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months) |
| Trail Making Test | 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. | From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months) |
| Stop-Signal Test | 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 | From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months) |
| Digit Span | 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. | From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months) |
| Wisconsin Card Sort Test | 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. | From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months) |
| 29063592 | Background | Vesco AT, Young AS, Arnold LE, Fristad MA. Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. J Child Psychol Psychiatry. 2018 Jun;59(6):628-636. doi: 10.1111/jcpp.12830. Epub 2017 Oct 24. |
| D004041 |
| Dietary Fats |
| D005223 | Fats |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |