Recruiting

Omega-3 & Subconcussive

Sponsor:

Indiana University

Code:

NCT06736925

Conditions

Subconcussive Head Impact

Omega-3 Fatty Acids

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Omega-3 Fatty Acids (EPA plus DHA)

Organic soybean oil

Soccer Heading Model

Study Details

Brief summary:

The purpose of the proposed double-blind, randomized placebo-controlled trial is to understand how supplementation with fish oil \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] promote brain health against soccer heading. The study involves taking DHA+EPA or placebo, questionnaires, blood draws, brain imaging, tests to evaluate heart function, and soccer headings.

Conditions

Subconcussive Head Impact

Omega-3 Fatty Acids

Study ID

NCT06736925

Start date

Feb 28, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Between age 18-30
  • Current or former soccer player
  • At least 5 years of soccer heading experience
  • Have internet access
  • Willing to commit to avoid any sport activity that purposefully uses one's head to maneuver during the study period (American football, ice-hockey, rugby, wrestling, and soccer heading).

Exclusion Criteria:

  • Any head or neck injury within 6 months before the study
  • Implanted metal/magnetic devices (e.g., orthodontic braces
  • Diagnosed autonomic or cardiovascular diseases (e.g., hypertension)
  • Consuming oily fish (2 servings or more/month: salmon, bluefin, swordfish, anchovies)
  • Allergy to fish or shellfish
  • Consuming omega-3 FA supplements including plant-based (e.g., flaxseed) in the past 3 months.
  • Pregnancy

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo: Organic soybean oil pills

We will use organic soybean oil pills ) as a placebo condition for the DHA+EPA group. One capsule contains 485 mg of organic soybean oil, including negligible amounts of DHA (1.1 mg), EPA (1.7 mg), and vitamin E (10 mg). Participants will ingest 5 capsules daily. Soybean oil is one of the most widely used vegetable oils in the world. Soybean oil contains polyunsaturated fats and 18-carbon omega-3 FA (total omega-3 FA of 73.9 mg per capsule), but very low levels of DHA and EPA, which makes it an excellent placebo counterpart when evaluating the effects of DHA/EPA. The placebo capsule's shelf life, composition, shape, size as the DHA+EPA active comparator.

active comparator: Omega-3 Fatty Acids (EPA plus DHA)

DHA+EPA capsules contain purified deep-sea fish oil, made from 100% wild-caught sardines and anchovies with a 3-year shelf life. The capsule shell is made from bovine limed bone with a size of 20 oblongs. Each soft gel capsule contains 480 mg of DHA, 205 mg of EPA, 145 mg of other omega-3 FA, and 10 mg of vitamin E. Participants in the DHA+EPA group will ingest 5 capsules daily \[a total of 3.4 g/d: DHA (2.4 g), EPA (1.0 g)\].

Interventions

Omega-3 Fatty Acids (EPA plus DHA)

DHA+EPA capsules contain purified deep-sea fish oil, made from 100% wild-caught sardines and anchovies with a 3-year shelf life. The capsule shell is made from bovine limed bone with a size of 20 oblongs. Each soft gel capsule contains 480 mg of DHA, 205 mg of EPA, 145 mg of other omega-3 FA, and 10 mg of vitamin E. Participants in the DHA+EPA group will ingest 5 capsules daily \[a total of 3.4 g/d: DHA (2.4 g), EPA (1.0 g)\].

Organic soybean oil

We will use organic soybean oil pills ) as a placebo condition for the DHA+EPA group. One capsule contains 485 mg of organic soybean oil, including negligible amounts of DHA (1.1 mg), EPA (1.7 mg), and vitamin E (10 mg). Participants will ingest 5 capsules daily. Soybean oil is one of the most widely used vegetable oils in the world. Soybean oil contains polyunsaturated fats and 18-carbon omega-3 FA (total omega-3 FA of 73.9 mg per capsule), but very low levels of DHA and EPA, which makes it an excellent placebo counterpart when evaluating the effects of DHA/EPA. The placebo capsule's shelf life, composition, shape, size as the DHA+EPA active comparator.

Soccer Heading Model

A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer (G-force tracker) embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 30 mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air.

Primary outcome measure

  • Blood Biomarkers [ Time Frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session ]
  • Diffusion Tensor Imaging [ Time Frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session ]
  • Sympathetic Reactivity [ Time Frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session ]
  • Near Point Convergence [ Time Frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session ]
  • King-Devick test [ Time Frame: Baseline, 24 hours following 1st and 2nd heading sessions, 7 days following the 2nd heading session ]

Central Contacts and Locations

Central contacts

Locations

Indiana University School of Public Health

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Principal Investigator:

Kei Kawata

More Information

Sponsor

Indiana University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Subconcussive brain injury
  • TBI
  • Soccer heading
  • Omega-3 fatty acids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-04-29.