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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Mindset2016-001-298 |
| Sponsor | Struct Nutrition, LLC |
| Funder | Struct Nutrition, LLC |
- 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
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
Scientific
2800 S University Dr
Fort Worth, TX
76129
United States of America
| Phone | (817) 257-5623 |
|---|---|
| jonathan.oliver@tcu.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter non-randomized interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Serum Nf-L levels. |
| Key secondary outcome measure(s) |
Plasma fatty acids levels sampled as above |
| Completion date | 15/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 100 |
| Total final enrolment | 66 |
| Key inclusion criteria | Players of NCAA Division I and III teams |
| Key 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. |
| Date of first enrolment | 31/05/2016 |
| Date of final enrolment | 15/09/2016 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Fort Worth, TX
76129
United States of America
La Crosse, WI
54601
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All 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? |
|---|---|---|---|---|---|
| Results article | control group results | 29/05/2018 | 07/10/2019 | Yes | No |
| Results article | results | 27/09/2021 | 29/09/2021 | Yes | No |
| Abstract results | conference abstract | 01/05/2018 | 07/10/2019 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
