Omega-3 Fatty Acids and Subconcussive Head Impacts

Indiana University

Status: Enrolling

Conditions: Omega-3 Fatty Acids; Subconcussive Head Impact

Treatments: Other: Soccer Heading Model; Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA); Dietary Supplement: Organic soybean oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06736925

21334

R01NS137276 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The purpose of the proposed study is to determine whether, and to what extent, supplementation with omega-3 fatty acids [docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)] can maintain or promote neural wellbeing against repetitive subconcussive head impacts. This study will also characterize what aspects of brain cellular and physiologic resiliencies are enhanced by supplementation in adult soccer players (aged 18-30 years old). A sub-cohort of participants who meet criteria for ADHD diagnosis will be part of exploratory analysises.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

208 participants in 2 patient groups, including a placebo group

Placebo: Organic soybean oil pills

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Organic soybean oil

Other: Soccer Heading Model

Omega-3 Fatty Acids (EPA plus DHA)

Active Comparator group

Description:

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 \[a total of 3.4 g/d: DHA (2.4 g), EPA (1.0 g)\].

Treatment:

Other: Soccer Heading Model

Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA)