CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Dietary Counselling combined with Omega-3 Supplementationcombination
Likely dose
Dietary Counselling combined with Omega-3 Supplementation 3456 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05573672
NCT05573672Phase 2Completed

Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder: A Randomized Wait-list Controlled Pilot Trial

The Canadian College of Naturopathic Medicine·interventional·Posted Oct 10, 2022·Updated Apr 4, 2025

In Brief

A Phase 2 clinical trial evaluating Dietary Counselling combined with Omega-3 Supplementation for Generalized Anxiety Disorder. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 10, 2022
Enrollment StartAug 12, 2022
Primary CompletionNov 30, 2023
TodayJul 3, 2026
Enrollment to primary: 1.3 yearsPosted 3.7 years ago

Interventions

Dietary Counselling combined with Omega-3 Supplementationcombination

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.