Omega-3 Supplementation and Mental Health in College Students (OMEGA-MH)

University of Colorado, Colorado Springs

Status: Completed

Conditions: Vitamin D; Mental Health

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Low dose Omega 3; Dietary Supplement: High dose Omega 3

Study type: Interventional

Funder types: Other

Identifiers

NCT07391254

2024-164

Details and patient eligibility

About

This randomized, placebo-controlled double blinded study examined whether placebo, low- or high dose omega 3 fatty acid supplementation had associations with mental health symptoms and vitamin D status in college students aged 18-27.

Full description

A 3-arm randomized design was employed where participants took 2 pills daily for 90 days. The first arm was a placebo, second arm was a low dose omega 3 and third arm was high dose omega 3. Mental health outcomes were measured using the GAD 7 questionnaire that measured anxiety, PHQ-9 which measured depression, and MSQ (Medical Symptoms Questionnaire) that assessed overall bodily symptoms. Vitamin D levels were also assessed as a secondary outcome.

Enrollment: 96 patients

Sex: All

Ages: 18 to 27 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18-27 years
• if taking antidepressants or enrolled in therapy, needs to be stable with at least 6 months or more of stable medication dose use and regular therapy appointments

Exclusion criteria

• age younger than 18 and older than 27
• not willing to take two capsules daily for 90 days
• not willing to get bloodwork
• has a history of fainting during bloodwork
• not willing to have anthropometrics measured
• not willing to have daily text reminders sent to phone
• currently has regularly taken omega 3 daily for at least 6 months
• currently has regularly taken vitamin D supplementation daily for at least 6 months
• allergic or sensitive to fish
• will not like to deal with potential "fish burps"
• utilized mental health services for less than 6 months
• taken an antidepressant for less than 6 months
• currently actively takes benzodiazepines
• currently actively takes sedatives or tranquilizers
• Currently is taking steroid supplements
• currently is taking steroid medications
• had surgery within the last 2 weeks or plans on having surgery within the next 3 months
• currently taking blood thinning medications
• takes NSAIDS regularly
• currently using a weight loss drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 3 patient groups, including a placebo group

PLacebo

Placebo Comparator group

Description:

Participants received placebo capsules daily for the duration of the study

Treatment:

Dietary Supplement: Placebo

Low dose Omega 3

Experimental group

Description:

Participants received 700 mg/day of omega 3

Treatment:

Dietary Supplement: Low dose Omega 3

High dose omega 3

Experimental group

Description:

Participants received 2150 mg/day of omega 3 fatty acids

Treatment:

Dietary Supplement: High dose Omega 3