NCT04844034

Brief Summary

This is a 12-week-long, randomised, double-blind, placebo-controlled trial exploring the efficacy of a high-EPA multinutrient supplement in the management of sub-clinical anxiety and depression. The investigators focus on young and healthy, adult university students, who may otherwise not be eligible for pharmacological or cognitive behavioural therapy interventions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

March 16, 2021

Last Update Submit

May 30, 2023

Conditions

AnxietyDepression

Keywords

AnxietyDepressionAnxiolyticAntidepressantOmega-3 PUFAsEicosapentaenoic AcidDocosahexaenoic AcidLong-chain Polyunsaturated Fatty AcidsDietary SupplementStressFunctional magnetic resonance imagingMagnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Anxiety on the 21-point Generalised Anxiety Disorder Assessment (GAD-7) at Week 12.

    GAD-7 is a 7-item, validated, self-reported instrument used to screen for generalised anxiety disorder and to assess its severity over the past two weeks. Possible scores range from 0 (none) to 21 (severe).

    Baseline and Week 12.

Secondary Outcomes (6)

  • Change from Baseline in Depression on the 24-point Patient Health Questionnaire (PHQ-8) at Week 12.

    Baseline and Week 12.

  • Change from Baseline in Depression, Anxiety and Stress on the 21-item Depression, Anxiety and Stress Scale (DASS-21) at week 12.

    Baseline and Week 12.

  • Change from Baseline in the Proportion of Trials Selected as Happy Compared to the Alternative Emotion, Adjusted to a Scale of 0 to 15 on the Emotional Bias Task (EBT) at Week 12.

    Baseline and Week 12.

  • Change from Baseline in Measures of Sustained Attention on the Rapid Visual Information Processing (RVP) at Week 12.

    Baseline and Week 12.

  • Change from Baseline in Measures of Retention and Manipulation of Visuospatial Information on Spatial Working Memory (SWM) at Week 12.

    Baseline and Week 12.

  • +1 more secondary outcomes

Other Outcomes (7)

  • Change from Baseline in Dietary Protein on 24-hour Dietary Intake Recall at Week 12.

    Baseline and Week 12.

  • Change from Baseline in Dietary Energy on 24-hour Dietary Intake Recall at Week 12.

    Baseline and Week 12.

  • Apolipoprotein E (APOE) and Fatty Acid Desaturase (FADS) Genotypes.

    Baseline.

  • +4 more other outcomes

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

High-EPA multinutrient supplement.

Dietary Supplement: High-EPA multinutrient supplement.

Placebo

PLACEBO COMPARATOR

Inert oil mix.

Other: Placebo

Interventions

High-EPA multinutrient supplement.DIETARY_SUPPLEMENT

Three capsules with the largest meal of the day providing: * 1,125 mg EPA * 441 mg DHA * 330 mg Magnesium * 7.5 mg a-tocopherol

Also known as: Libretto
Active treatment
PlaceboOTHER

Three capsules with the largest meal of the day providing: * 3,060 mg sunflower seed oil * 60 mg lecithin * 300 mg glyceryl monostearate * 465 mg EPA/DHA (18%/12% respectively for blinding)

Placebo

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-29 years
  • GAD-7 Score ≥ 5
  • PHQ-8 Score ≥ 4
  • English language fluency.
  • Overall good health.

You may not qualify if:

  • Self reported BMI ≥ 30 kg/m\^2.
  • Current tobacco smoker.
  • Diagnosis of anxiety, depression/major depressive disorder episode, psychosis, schizophrenia, bipolar disorder, eating disorders, haemophilia, or life-threatening disease during the preceding six months from the beginning of the trial.
  • Use of antidepressant drugs during the preceding six months from the beginning of the trial.
  • Participation to psychological and/or behavioural interventions during the preceding six months from the beginning of the trial.
  • Inability to ingest pills.
  • Pregnancy.
  • Breastfeeding.
  • Known allergy or intolerance to LCn-3 PUFAs, seafood and any of the constituents of the supplement under investigation.
  • High intake (more than twice per week) of oily fish (e.g. herring, pilchards, salmon, swordfish, sardines, sprats, trout or mackerel).
  • Use of fish oil supplements during the preceding six months from the beginning of the trial.
  • Inability to participate in the study for 12 consecutive weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Roehampton

London, SW15 4JD, United Kingdom

RECRUITING

Related Publications (13)

  • Gravielle MC. Activation-induced regulation of GABAA receptors: Is there a link with the molecular basis of benzodiazepine tolerance? Pharmacol Res. 2016 Jul;109:92-100. doi: 10.1016/j.phrs.2015.12.030. Epub 2015 Dec 28.

    PMID: 26733466BACKGROUND

  • Masand PS, Gupta S. Long-term side effects of newer-generation antidepressants: SSRIS, venlafaxine, nefazodone, bupropion, and mirtazapine. Ann Clin Psychiatry. 2002 Sep;14(3):175-82. doi: 10.1023/a:1021141404535.

    PMID: 12585567BACKGROUND

  • Firth J, Teasdale SB, Allott K, Siskind D, Marx W, Cotter J, Veronese N, Schuch F, Smith L, Solmi M, Carvalho AF, Vancampfort D, Berk M, Stubbs B, Sarris J. The efficacy and safety of nutrient supplements in the treatment of mental disorders: a meta-review of meta-analyses of randomized controlled trials. World Psychiatry. 2019 Oct;18(3):308-324. doi: 10.1002/wps.20672.

    PMID: 31496103BACKGROUND

  • O' Donovan F, Carney S, Kennedy J, Hayes H, Pender N, Boland F, Stanton A. Associations and effects of omega-3 polyunsaturated fatty acids on cognitive function and mood in healthy adults: a protocol for a systematic review of observational and interventional studies. BMJ Open. 2019 Jun 22;9(6):e027167. doi: 10.1136/bmjopen-2018-027167.

    PMID: 31230010BACKGROUND

  • LeBlanc, N. J., Brown, M., & Henin, A. (2020). Anxiety Disorders in Emerging Adulthood. In E. Bui, M. E. Charney, & A. W. Baker (Eds.), (pp. 157-173).

    BACKGROUND

  • Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

    PMID: 18752852BACKGROUND

  • Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.

    PMID: 27187854BACKGROUND

  • Mathias RA, Pani V, Chilton FH. Genetic Variants in the FADS Gene: Implications for Dietary Recommendations for Fatty Acid Intake. Curr Nutr Rep. 2014 Jun;3(2):139-148. doi: 10.1007/s13668-014-0079-1.

    PMID: 24977108BACKGROUND

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND

  • Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.

    PMID: 21784145BACKGROUND

  • McNamara RK, Strawn JR, Tallman MJ, Welge JA, Patino LR, Blom TJ, DelBello MP. Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial. J Child Adolesc Psychopharmacol. 2020 Jun;30(5):293-305. doi: 10.1089/cap.2019.0124. Epub 2020 Mar 11.

    PMID: 32167792BACKGROUND

  • McNamara RK, Li W, Lei D, Tallman MJ, Welge JA, Strawn JR, Patino LR, DelBello MP. Fish oil supplementation alters emotion-generated corticolimbic functional connectivity in depressed adolescents at high-risk for bipolar I disorder: A 12-week placebo-controlled fMRI trial. Bipolar Disord. 2022 Mar;24(2):161-170. doi: 10.1111/bdi.13110. Epub 2021 Jul 23.

    PMID: 34214231BACKGROUND

  • Kelaiditis CF, Gibson EL, Dyall SC. 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 Leukot Essent Fatty Acids. 2021 Oct;173:102335. doi: 10.1016/j.plefa.2021.102335. Epub 2021 Aug 25.

    PMID: 34461561DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Leigh Gibson, PhD

    University of Roehampton

    STUDY DIRECTOR

  • Simon Dyall, PhD

    University of Roehampton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Kelaiditis, MSc

CONTACT

+447453264577kelaidic@roehampton.ac.uk

Simon Dyall, PhD

CONTACT

+442083923538simon.dyall@roehampton.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 16, 2021

First Posted

April 14, 2021

Study Start

April 19, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Data will be: * Fully anonymised * Stored for 8 years as per University of Roehampton's Research Ethics Committee guidelines and Code of Practice. * Appended to the final published report as supplemental material. * Available from the corresponding author upon request. * Handled, processed, stored and destroyed as per Data Protection Act (2018). * Collected in Microsoft Excel worksheets in one file per type of experiment including original and normalised values; images/graphs will be stored as .tiff or .jpg files. * Held encrypted on password-protected, university-owned drives. * Accessible only by the investigators. * Submitted for publication within one year. * Deposited in a public preprint server (e.g. bioRxiv). Additional files with legends explaining how the data has been saved and described will be prepared to allow replicability. All anonymised data volumes are expected to be small. Long-term backup/archiving will utilise secure in-house facilities and cloud-based storage.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will become available upon publication of the study report and will remain available for eight years in accordance with the University of Roehampton's Research Ethics Code of Practice.
Access Criteria
Fully anonymised data will be available from the corresponding author upon request.

Locations

GB(1)