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Generalized Anxiety DisorderPhase 2EASe-GADNCT05573672

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

A Phase 2 study testing Dietary Counselling combined with Omega-3 Supplementation in people with Generalized Anxiety Disorder, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Dietary Counselling combined with Omega-3 Supplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
12 Aug 2022to 30 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A person aged 18-65 years who currently identifies as a woman.
  • Primary diagnosis of generalized anxiety disorder based on a clinical interview with a psychiatrist using the DSM-5 criteria.
  • Moderate to severe anxiety as defined as a Beck Anxiety Inventory score of 22 or higher.
  • Low quality diet as defined as a score of 8.5 or less on the MEDI-LITE tool.
  • All psychiatric medication, psychotherapy and natural health products stable for the past four weeks.
  • Established therapeutic relationship with a family doctor, psychiatrist, or clinical psychologist as their primary source of mental health care.
  • Ability to swallow capsules.
  • Ability to read in English and provide informed consent

Who cannot join

  • Currently meets DSM-5 criteria for obsessive-compulsive disorder, bipolar disorder, a psychotic disorder, an eating disorder, or substance use disorder based on clinical interview with a psychiatrist.
  • Current high level of suicidality assessed by trial psychiatrist using the Columbia Suicide Severity Scale.
  • Starting or changing the dose of a psychiatric medication, psychotherapy, or natural health products in the past four weeks.
  • Severe food allergies, intolerances or aversions that would prevent the individual from modifying their diet (includes aversion to bovine gelatin which is a component of the fish oil supplement).
  • Current participation in a program, research study or treatment plan involving diet or lifestyle modification.
  • Baseline Omega Score of >5% (suggesting adequacy of omega-3 fatty acids).
  • Supplementation of greater than 4000IU of vitamin D daily for at least one month in the previous six months.
  • Allergy to fish or any of the non-medicinal ingredients in the study product.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Canadian College of Naturopathic Medicine

    Toronto, Ontario, M2K 1E2

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Dietary Counselling combined with Omega-3 Supplementation
Keywords
anxiety, generalized anxiety disorder, nutrition, diet, omega-3, lifestyle
Medical subject headings
Generalized Anxiety Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Counselling combined with Omega-3 SupplementationCombination product

    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.

Study groups in NCT05573672
Study groupRoleWhat they receive
Immediate StartExperimentalDietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation
Receives: Combination Product: Dietary Counselling combined with Omega-3 Supplementation
Waitlist ControlNo interventionParticipants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Participant Recruitment and Intervention Delivery

    Feasibility will be assessed by measuring the time to recruit and enrol 50 participants. Additionally, we will compare the intervention protocol with the intervention activities delivered.

    Measured: 8 months

  2. Acceptability of the Intervention by Study Participants

    Acceptability will be assessed by measuring the number of diet counselling sessions completed. Additionally, 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.

    Measured: 12 weeks

Secondary outcomes (12)

  1. Anxiety Symptom Severity: The Beck Anxiety Inventory

    The Beck Anxiety Inventory is a validated 21-item self-report inventory for measuring the severity of anxiety in participants with psychiatric illness. Answers to each item are given a score of 0 (not at all), 1 (mild), 2 (moderate) or 3 (severely), total scores range from 0 to 63 (minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63)). The Beck Anxiety Inventory will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  2. Diet Quality: MEDI-LITE Questionnaire

    MEDI-LITE is a validated questionnaire that measures daily and weekly consumption of food typical and non-typical to the Mediterranean diet. Typical Mediterranean diet foods are scored 2 for high consumption, 1 more moderate and 0 for low. Non-typical Mediterranean diet foods are scored 2 for low consumption, 1 for moderate and 0 for high. Scores range from 0 (low consumption) to 18 (high consumption). The MEDI-LITE questionnaire will be completed to assess adherence to the Mediterranean diet at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  3. Quality of Life: PROMIS-29 v2.1

    The PROMIS-29 is a validated scale using 4 items scored on a 1-5 scale on intensity to assess 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities and pain interference). Higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function). PROMIS-29 will be used to assess quality of life at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  4. Mindful Eating Behaviour: Mindful Eating Questionnaire

    The MEQ is a 28-item scale that measures five factors associated with mindful eating (emotional responses, distraction, external cues, awareness and disinhibition). The questionnaire will be used to measure behaviour change and qualitatively assess the acceptability of the intervention. Each item is scored on a 1-4 scale, higher scores signify more mindful eating. The scores are added together and divided by the number of items answered to get a total summary score. The minimum score is 1 and the maximum score is 4. The MEQ will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  5. Self Efficacy: General Self-Efficacy Scale

    The GSE is a 10-item validated questionnaire that measures an individual's belief in their ability to overcome and respond to difficult scenarios. Answers to each item are given a score of 0 (not at all true), 1 (barely true), 3 (moderately true) or 4 (exactly true), higher scores correlate to greater self-efficacy. The minimum score is 10 and the maximum score is 40. The GSE will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  6. OmegaScore

    Summed EPA, DHA and DPA as a percentage of total fatty acids in whole blood as a measure of omega-3 status. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  7. Fasting Cholesterol Panel

    Measures of serum cholesterol including LDL, HDL, triglycerides and total cholesterol. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  8. Hemoglobin A1c

    Measure of the average blood sugar in the past 3 months. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  9. Serum Vitamin C

    Measure of serum levels of vitamin C as an objective marker for fruit and vegetable intake. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  10. Serum Beta-carotene

    Measure of serum levels of beta-carotene as an objective marker for fruit and vegetable. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  11. C-reactive Protein

    CRP will be used to measure inflammation levels. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

  12. HOMA-IR

    Homeostatic Model Assessment of Insulin Resistance, calculated using fasting insulin and fasting glucose. Formula: fasting glucose (mg/dL) X fasting insulin (mU/L) / 405. A higher value suggests more insulin resistance. These blood tests and calculation will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start12 Aug 2022
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be wait-list controlled. Participants will be randomized to one of two groups. One group will begin the intervention immediately. The other will wait 12 weeks and then complete the intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573672
Sponsor's protocol ID
CCNM_EASe-GADCT_2201v3
Acronym
EASe-GAD
Status last verified
Mar 2025
First submitted
4 Oct 2022
Last updated
4 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aucoin M, LaChance L, van der Wurff I, McLaren M, Monteiro S, Miller S, Jenkins A, Sabri E, Cooley K. Dietary counseling plus omega-3 supplementation in the treatment of generalized anxiety disorder: results of a randomized wait-list controlled pilot trial (the 'EASe-GAD Trial'). Nutr Neurosci. 2025 Jun;28(6):635-648. doi: 10.1080/1028415X.2024.2403901. Epub 2024 Sep 24.

    PubMed 39316026

  • Aucoin M, LaChance L, van der Wurff I, Miller S, Naidoo U, Jenkins A, Cooley K. Dietary counselling plus omega-3 supplementation in the treatment of generalized anxiety disorder: protocol for a randomized wait-list controlled pilot trial (the "EASe-GAD Trial"). Pilot Feasibility Stud. 2023 Nov 10;9(1):186. doi: 10.1186/s40814-023-01414-y.

    PubMed 37950301

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dietary Counselling combined with Omega-3 Supplementation in people with Generalized Anxiety Disorder, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Participant Recruitment and Intervention Delivery (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05573672, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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