Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Recognizing the potential neuroprotective effect of omega-3 fatty acids administration was the foundation of the current study. The typical American diet is scarce in omega-3 fatty acids with an estimated combined intake of about 100 mg/day. As such, we sought to examine the effect of supplemental omega-3 fatty acids on changes in a surrogate biological marker of neurological injury, serum Nf-L, over the course of a competitive season in American football athletes. We hypothesized that those American football athletes supplemented with omega-3 fatty acids throughout the duration of their competitive season would exhibit lower levels of serum Nf-L throughout the course of the season compared to their counterparts not supplementing with omega-3 fatty acids.

Who can participate?
NCAA players from the selected teams

What does the study involve?
American football exposes athletes to subconcussive repetitive head impacts (RHI). Subconcussive RHI elevate serum neurofilament light (Nf-L), a biomarker of axonal injury. This study involves if Omega-3 fatty acid supplementation in American football athletes blunt the symptoms of RHI through decreasing Nf-L biomarker

What are the possible benefits and risks of participating?
Since this study does not impact the nature of American Football, there is no additional risk to be expected. Potential benefits could be that Omega-3 fatty acids improve RHI symptoms

Where is the study run from?
1. Texas Christian University, USA
2. Wisconsin La Crosse University, USA

When is the study starting and how long is it expected to run for?
May 2016 to December 2017

Who is funding the study?
Struct Nutrition, LLC, USA

Who is the main contact?
Dr Jonathan Oliver

Trial website

Contact information



Primary contact

Dr Jonathan Oliver


Contact details

2800 S University Dr
Fort Worth
United States of America
(817) 257-5623

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number


Study information

Scientific title

Effect of a nutritional, proprietary omega-3 fatty acid formulation on serum Nf-L levels in NCAA football athletes over the course of a season


Study hypothesis

NCAA college football athletes supplemented with omega-3 fatty acids throughout the duration of their competitive season would exhibit lower levels of serum Nf-L throughout the course of the season compared to their counterparts not supplementing with omega-3 fatty acids.

Ethics approval

Approved 19/05/2016, TCU Institutional Review Board (Office of Research, Sadler Hall, Suite 3101
Fort Worth, Texas 76129;; +1 817 257 7104), ref: 1605-053-1605

Study design

Multicenter non-randomized interventional study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

No participant information sheet available


Nutritional invervention study in a healthy, athletic, male population


Multicenter, non-randomized, interventional study design examining the effect of daily supplementation with highly bioavailable omega-3 fatty acids on plasma fatty acids levels, and peripheral levels of Nf-L over the course of an NCAA American football season. This study recruited participants from two geographically distinct NCAA American football teams. The team that received supplementation was a NCAA Division I team, while the control team competed at the NCAA Division III level.

One team received treatment of omega-3 FA and the other team was control and received placebo. Blood was sampled at specific times before, during and after the during pre-season and regular season that coincided with changes in sport intensity, physical contact, and likely changes in incidence and severity of head impacts.

Intervention type



Drug names

Primary outcome measure

Serum Nf-L levels.
Blood was obtained from participants at various time points chosen to coincide with changes in practice intensity, the amount of physical contact, and the number and magnitude of head impacts

Secondary outcome measures

Plasma fatty acids levels sampled as above

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Players of NCAA Division I and III teams

Participant type

Healthy volunteer

Age group




Target number of participants


Participant exclusion criteria

1.Younger than 18 years of age
2. The use of long-term anti-inflammatory therapy (≥ 20 days)
3. The use of anti-hypertensive medications
4. The use of medications known to affect blood lipids
5. The consumption of fish oil or omega-3 FA supplementation
6. Self-reported consumption of more than two servings of fish per week
7. Athletes who were injured (including concussive injuries), became ill, were unable to participate in regularly scheduled conditioning, practice, or competitions, or those who did not meet the threshold compliance standards for daily supplementation (≥ 80%) were excluded.

Recruitment start date


Recruitment end date



Countries of recruitment

United States of America

Trial participating centre

Texas Christian University (TCU)
2800 S University Dr
Fort Worth, TX
United States of America

Trial participating centre

University of Wisconsin - La Crosse
1725 State St
La Crosse, WI
United States of America

Sponsor information


Struct Nutrition, LLC

Sponsor details

135 W Main St.
Suite B
United States of America
(877) 549-9123

Sponsor type




Funder type


Funder name

Struct Nutrition, LLC

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

We plan to publish the results of this study in two different publications, one paper describing the results of the control group, the other describing the results of the group supplemented with omega-3s.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

2018 control group results in: (added 07/10/2019)
2018 conference abstract in: (added 07/10/2019)

Publication citations

Additional files

Editorial Notes

15/10/2019: Trial’s existence confirmed by TCU IRB