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The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial.

Prostaglandins, leukotrienes, and essential fatty acids
October 1, 2021
Christos F Kelaiditis et al. (3 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the effects of a high eicosapentaenoic acid multinutrient supplement on anxiety and depression in healthy university students with non-clinical levels of these conditions.

Results Summary

The abstract describes the study protocol but does not report results, as it is a trial registration.

Population

Healthy university students aged 18-29 experiencing non-clinical levels of anxiety and depression.

Effective Dosage

1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium, and 7.5 mg vitamin E daily.

Duration

24 weeks

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients
decrease
anxiety disorders
young adults aged 18-29 years
-
gaining recognition as safe and effective alternatives
#1
high eicosapentaenoic acid multinutrient supplement
neutral
validated measures of anxiety and depression
healthy university students experiencing non-clinical levels of anxiety and depression
-
investigating the effects
#2
high eicosapentaenoic acid multinutrient supplement
decrease
anxiety
healthy university students experiencing non-clinical levels of anxiety and depression
-
improvement in anxiety compared to the placebo group
#3
active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E
neutral
validated questionnaires and tablet-based tasks sensitive to mood
healthy university students experiencing non-clinical levels of anxiety and depression
-
will be randomised to
#4
active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E
neutral
circulating fatty acids and key biomarkers
healthy university students experiencing non-clinical levels of anxiety and depression
-
will be assessed
#5
long-chain omega-3 polyunsaturated fatty acids
neutral
affect
students
-
influence the relationship
#6
Abstract

Anxiety disorders affect nearly 20% of young adults aged 18-29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034.

Medical Subject Headings (MeSH)
AdolescentAdultAnxietyDepressionDietary SupplementsDocosahexaenoic AcidsDouble-Blind MethodEicosapentaenoic AcidFemaleHumansMagnesiumMalePatient Health QuestionnaireRandomized Controlled Trials as TopicStress, PsychologicalVitamin EYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations1
Citations/Year0.3
Relative Citation Ratio0.13
NIH Percentile6.6%
Research Impact Scores
APT Score0.05
Weight Score2.21
Normalized Score0.57
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The effects of a high eicosapentaenoic acid multinutrient su... | Panacea Index