Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder

NCT05573672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-04

Study results available
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Summary

This study will assess the feasibility and acceptability of a combination intervention including dietary counselling and omega-3 fatty acid supplementation among women with generalized anxiety disorder. It will be randomized and wait-list controlled with 25 participants completing the 12-week intervention immediately and the other 25 participants completing the intervention after a 12-week wait period.

Conditions

  • Generalized Anxiety Disorder

Interventions

COMBINATION_PRODUCT

Dietary Counselling combined with Omega-3 Supplementation

Dietary Counselling: Seven, bi-weekly counselling sessions over 12-weeks conducted by a licensed Naturopathic Doctor. Each session will be 45-60 minutes in length. The recommendations will be based on the Mediterranean diet and the results of a recent scoping review which summarized the research related to diet and anxiety. The intervention will include motivational interviewing, mindful eating techniques, goal setting and action planning. A range of resources related to meal planning, recipes, cooking education, shopping lists and tracking sheets will be provided in an individualized manner. Dietary Supplement: AquaOmega High EPA Omega-3 capsules will be taken at a dose of four capsules, once daily (containing a total of 3456 mg of omega-3 fatty acids: 2659mg of Eicosapentaenoic acid (EPA), 532mg of docosahexaenoic acid (DHA), and 800IU of Vitamin D), with a meal.

Sponsors & Collaborators

  • McGill University

    collaborator OTHER
  • Netherlands Open University

    collaborator OTHER
  • Massachusetts General Hospital

    collaborator OTHER
  • Ekhagastiftelsen

    collaborator OTHER
  • AquaOmega

    collaborator UNKNOWN
  • Lipid Analytical Laboratories Inc

    collaborator UNKNOWN
  • Mitacs

    collaborator INDUSTRY
  • The Canadian College of Naturopathic Medicine

    lead OTHER

Principal Investigators

  • Monique Aucoin, ND MSc · Canadian College of Naturopathic Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573672 on ClinicalTrials.gov