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
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
- 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
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