An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- n-3 fatty acid intake
研究概览
简要总结
This is an observational case-control add-on study to an investigator-initiated clinical trial (IICT) (ClinicalTrials.gov Identifier: NCT03167307): Omega-3 fatty acids as firstline treatment in pediatric depression. A 36-week multi-centre, double-blind, placebo-controlled randomized superiority study.
This project will recruit a healthy control group matched for age and sex to a sub-group of patients with diagnosed pediatric major depressive disorder (pMDD) enrolled in the IICT. The aim is to investigate the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD, and explore potential biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health and cognitive function.
详细描述
According to a recent school survey, one out of ten adolescents in Zurich have moderate to marked depressive symptoms. Early onset of paediatric major depressive disorder (pMDD) is a risk factor for chronic and recurrent forms of depression in adulthood (MDD). MDD is associated with difficulties in relationships, impaired school and work performance, and an increased risk of substance abuse. Furthermore, MDD is a major contributor to the burden of suicide and poor long-term health late in life. The emerging potential of n-3 polyunsaturated fatty acids (n-3 PUFAs), also known in short as omega-3 fatty acids (n-3 FAs), for the treatment of MDD is being investigated in several studies. Previous observational studies suggest a link between the consumption of n-3PUFA-rich food and the level of depressive symptoms. However, studies that investigated the potential beneficial effects of n-3 PUFA supplementation for the treatment of MDD compared with placebo showed inconsistent findings.
Primary objectives of this project are:
- To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD.
- To explore biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health, cognitive function, and potential pathways linking n-3 FA intake/status and brain health (e.g. immune system, gut microbiome-brain-axis).
Participants meeting the following criteria are eligible for the study:
Inclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants of female and male sex
- •Children aged 8 to ≤ 13 years or teenagers 13 to < 18 years at time of study entry
- •Written informed assent of the subject (appendix informed consent forms) and written in formed consent form from the subjects' parents/legal representatives
- •No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test.
- •No use of chronic medication
- •Able to communicate in German; degree of understanding sufficient to comply with trial procedure
排除标准
- •More than 4 weeks of regular n-3 FA supplementation (>2 daily capsules standard strength providing > 600 mg combined EPA/DHA) within the last 6 months.
- •Women who are self-reported pregnant or breast feeding.
- •Self-reported pre-existing neurological (such as e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy) or medical conditions (ICD-10 F06-F07) likely to be a risk factor for developing depressive symptoms
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
结局指标
主要结局
n-3 fatty acid intake
时间窗: 6 months
Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire
n-3 fatty acid status
时间窗: 1 day
Measurement of relative amount of n-3 fatty acids
Pediatric depressive symptoms
时间窗: 2 weeks
Quantification of depressive symptoms with "Children's Depression Rating Scale - Revised" (CDRS-R) total score; Scale from 17 to \>72; values \>40 rated as moderate depression
次要结局
- Biomarkers related to gut microbiota(1 day)
- Biomarkers related to brain health(1 day)
- Biomarkers related to systemic inflammation(1 day)
- Fatty acid metabolism(1 day)
- Biomarkers related to nutritional status(1 day)