Impact of Omega-3 Supplementation on Omega-3 Status, Vitamin D and Mood in College Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The coordinators recruiting and measuring
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PLacebo
Participants received placebo capsules daily for the duration of the study
干预措施: Placebo (Dietary Supplement)
Low dose Omega 3
Participants received 700 mg/day of omega 3
干预措施: Low dose Omega 3 (Dietary Supplement)
High dose omega 3
Participants received 2150 mg/day of omega 3 fatty acids
干预措施: High dose Omega 3 (Dietary Supplement)
结局指标
主要结局
Anxiety
时间窗: Baseline to end of intervention (90 days)
GAD-7 (Summed 0-21 with higher scores indicating more anxiety)
Depression Symptoms
时间窗: Baseline to end of intervention (90 days)
PHQ-9 (Summed for a score of 0-27, the higher the score the more depression)
次要结局
- Vitamin D(Baseline to end of intervention (90 days))
- Medical Symptom Burden(Baseline to end of intervention (90 days))
研究者
Margaret Harris
Associate Professor
University of Colorado, Colorado Springs