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An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents

An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04158869
Enrollment
190
Registered
2019-11-12
Start date
2019-09-16
Completion date
2020-12-22
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Mental Disorder, Depression, Major Depressive Disorder

Keywords

n-3 fatty acids, pediatric Major Depressive Disorder

Brief summary

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.

Detailed description

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: 1. To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD. 2. 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: * 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 and written informed consent from the subject's parents/legal representatives * No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test Exclusion criteria: * More than 4 weeks of regular n-3 FA supplementation * Women who are self-reported pregnant or breast feeding * Pre-existing neurological or medical conditions likely to be a risk factor for developing depressive symptoms In a first step participants will be screened for in- and exclusion criteria. If participants can be included into the study we will * Measure participant's mental health with behavioural and cognitive assessments * Collect biological samples from participants (blood, urine, saliva, hair, and stool) This study aims to recruit a total of 200 participants: 100 cases (from IICT) and 100 controls (recruited for this study). There will be a total recruiting period of 18 months.

Interventions

None listed

Sponsors

Psychiatric University Hospital, Zurich
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

For cases: participants enrolled in the IICT and therefore meeting the criterie for participation in the IICT will be selected. For controls, participants fulfilling all of the following inlclusion criterie are eligible for the study Inclusion Criteria: * 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
n-3 fatty acid intake6 monthsEstimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire
n-3 fatty acid status1 dayMeasurement of relative amount of n-3 fatty acids
Pediatric depressive symptoms2 weeksQuantification 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

Secondary

MeasureTime frameDescription
Biomarkers related to gut microbiota1 dayMeasurement of * gut microbiome composition with 16S rRNA sequencing * Faecal calprotectin * Intestinal fatty acid binding protein
Fatty acid metabolism1 dayMeasurement of lipid mediators
Biomarkers related to nutritional status1 dayMeasurement of iron and iodine status
Biomarkers related to brain health1 dayMeasurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters
Biomarkers related to systemic inflammation1 dayMeasurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines

Other

MeasureTime frameDescription
Scale of Impulsivity and Emotion Dysregulation (IES-27)1 monthDifferences in scores between cases and controls
Childhood Trauma Questionnaire (CTQ)1 dayDifferences in scores between cases and controls
Strenght and Difficulty Questionnaire (SDQ)1 dayDifferences in scores between cases and controls
Verbal learning and memory test (VLMT)1 dayDifferences in scores between cases and controls
Children's Depression Inventory (DIKJ)1 monthDifferences in scores between cases and controls
Connor Davidson Resilience Scale (CDRS)1 monthDifferences in scores between cases and controls
Beck Anxiety Inventory (BAI)1 monthDifferences in scores between cases and controls
Perceived Stress Scale (PSS-10)1 monthDifferences in scores between cases and controls
Behavior Rating Inventory of Executive Function (BRIEF)1 dayDifferences in the overall score between cases and controls
Digit span measured by the Wechsler Intelligence Scale for children (WISC-IV)1 dayDifferences in scores between cases and controls
Emotion recognition measured with the Amsterdam Neuropsychological Task (ANT) program1 dayDifferences in scores between cases and controls
Attentional flexibility measured with the shifting attentional set of the Amsterdam Neuropsychological Task (ANT) program1 dayDifferences in reaction times between cases and controls
Regensburg Word Fluency Test (RWT)1 dayDifferences in scores between cases and controls
Reynolds Intellectual Assessment Scales (RIAS)1 dayDifferences in scores between cases and controls
Suicidal ideation Questionnaire (SIQ)1 monthDifferences in scores between cases and controls

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026