Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/10/2019
Date assigned
15/10/2019
Last edited
15/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
jonathan.oliver@tcu.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Oliver

ORCID ID

Contact details

2800 S University Dr
Fort Worth
TX
76129
United States of America
(817) 257-5623
jonathan.oliver@tcu.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Mindset2016-001-298

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

Acronym

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; research@tcu.edu; +1 817 257 7104), ref: 1605-053-1605

Study design

Multicenter non-randomized interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Nutritional invervention study in a healthy, athletic, male population

Intervention

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

Supplement

Phase

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

01/03/2016

Overall trial end date

15/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Players of NCAA Division I and III teams

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

100

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

31/05/2016

Recruitment end date

15/09/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

Texas Christian University (TCU)
2800 S University Dr
Fort Worth, TX
76129
United States of America

Trial participating centre

University of Wisconsin - La Crosse
1725 State St
La Crosse, WI
54601
United States of America

Sponsor information

Organisation

Struct Nutrition, LLC

Sponsor details

135 W Main St.
Suite B
Missoula
MT
59802
United States of America
(877) 549-9123
lkolb@tsiinc.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Struct Nutrition, LLC

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/12/2019

Participant level data

Other

Basic results (scientific)

Publication list

2018 control group results in: https://www.ncbi.nlm.nih.gov/pubmed/29807487 (added 07/10/2019)
2018 conference abstract in: https://www.researchgate.net/publication/325633168_Neuroprotective_Effect_of_Omega-3_Fatty_Acids_on_Head_Trauma_in_American_Football_Athletes (added 07/10/2019)

Publication citations

Additional files

Editorial Notes

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