NCT05573672

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Canadian College of Naturopathic Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Generalized Anxiety Disorder (GAD) is a common mental health disorder involving high levels of worry or tension. The symptoms are persistent and distressing and interfere with an individual's functioning and quality of life. Clinical evidence suggests that nutritional interventions, based on the Mediterranean diet and omega-3 fatty acid supplementation improve the symptoms of depression. To date, the effect of diet change interventions on anxiety symptoms has not been studied in trials involving people with diagnosed anxiety disorders. The primary objective of this study is to test the feasibility and acceptability of a dietary counselling and omega-3 fatty acid supplementation intervention delivered to adult women with GAD. The secondary objectives include measuring changes in anxiety symptom severity, measuring changes in quality of life, measuring changes in biomarkers and evaluation of the components of the program. This study is a randomized, wait-list controlled pilot trial delivering a 12-week, dietary counselling intervention and omega-3 supplementation to 50 adult women with GAD. Participant will complete seven individual counselling sessions which include nutrition education, personalized recommendations, mindful eating techniques, motivational interviewing, and goal setting. They will be provided with recipes, instructional videos, and food items. Questionnaires and blood work will be completed at baseline, after the wait period (for those in the wait-list group) and after the intervention. The questionnaires will measure changes in anxiety symptom severity, quality of life, diet quality, mindful eating behaviours, and self-efficacy and lab tests will measure changes in biomarkers of nutritional status. All participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction. Additional information will be collected to characterize study participants including demographic information, body mass index, physical activity and food security. Results from this study will lay the foundation for future large-scale studies in this area and may provide preliminary evidence of the role of diet counselling and omega-3 supplementation in the management of GAD.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-12
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2022-10-10
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

1 site across 1 country: Canada