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)