Can a nutritional omega-3 fatty acid formulation improve brain health in NCAA football athletes over the course of a season?

ISRCTN ISRCTN90306741
DOI https://doi.org/10.1186/ISRCTN90306741
Secondary identifying numbers Mindset2016-001-298
Submission date
04/10/2019
Registration date
15/10/2019
Last edited
29/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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
jonathan.oliver@tcu.edu

Contact information

Dr Jonathan Oliver
Scientific

2800 S University Dr
Fort Worth, TX
76129
United States of America

Phone (817) 257-5623
Email jonathan.oliver@tcu.edu

Study information

Study designMulticenter non-randomized interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleEffect 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 objectivesNCAA 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(s)Approved 19/05/2016, TCU Institutional Review Board (Office of Research, Sadler Hall, Suite 3101
Fort Worth, Texas 76129; research@tcu.edu; +1 817 257 7104), ref: 1605-053-1605
Health condition(s) or problem(s) studiedNutritional invervention study in a healthy, athletic, male population
InterventionMulticenter, 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 typeSupplement
Primary outcome measureSerum 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 measuresPlasma fatty acids levels sampled as above
Overall study start date01/03/2016
Completion date15/12/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexMale
Target number of participants100
Total final enrolment66
Key inclusion criteriaPlayers of NCAA Division I and III teams
Key exclusion criteria1.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.
Date of first enrolment31/05/2016
Date of final enrolment15/09/2016

Locations

Countries of recruitment

  • United States of America

Study participating centres

Texas Christian University (TCU)
2800 S University Dr
Fort Worth, TX
76129
United States of America
University of Wisconsin - La Crosse
1725 State St
La Crosse, WI
54601
United States of America

Sponsor information

Struct Nutrition, LLC
Industry

135 W Main St.
Suite B
Missoula, MT
59802
United States of America

Phone (877) 549-9123
Email lkolb@tsiinc.com

Funders

Funder type

Industry

Struct Nutrition, LLC

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planWe 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 planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results conference abstract 01/05/2018 07/10/2019 No No
Results article control group results 29/05/2018 07/10/2019 Yes No
Results article results 27/09/2021 29/09/2021 Yes No

Editorial Notes

29/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
15/10/2019: Trial’s existence confirmed by TCU IRB