Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder
CompletedPhase 2Results postedLast updated 4 April 2025
What this trial tests
Phase 2 trial testing Dietary Counselling combined with Omega-3 Supplementation in Generalized Anxiety Disorder in 50 participants. Completed in 30 November 2023.
Timeline
12 August 2022
Primary endpoint 30 November 2023
30 November 2023
Quick facts
Lead sponsor
The Canadian College of Naturopathic Medicine
Phase
Phase 2
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
single
Primary purpose
treatment
Enrollment
50
Start date
12 August 2022
Primary completion
30 November 2023
Estimated completion
30 November 2023
Sites
1 location across Canada
Drugs / interventions tested
Dietary Counselling combined with Omega-3 Supplementation
Adults 18 to 65, any sex, with Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of Participant Recruitment and Intervention DeliveryPrimary· 8 months
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.
Group
Value
95% CI
Immediate Start
8
Waitlist Control
8
Acceptability of the Intervention by Study ParticipantsPrimary· 12 weeks
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.
Group
Value
95% CI
Immediate Start
6.4
± 1.5
Waitlist Control
6.4
± 1.9
Anxiety Symptom Severity: The Beck Anxiety InventorySecondary· 12 weeks
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.
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.
Baseline
Group
Value
95% CI
Immediate Start
7.2
6.32 – 8.10
Waitlist Control
7.1
6.33 – 7.91
12 Weeks
Group
Value
95% CI
Immediate Start
10.5
9.55 – 11.49
Waitlist Control
6.9
6.17 – 7.74
Quality of Life: PROMIS-29 v2.1Secondary· 12 weeks
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.
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
MEQ, baseline
Group
Value
95% CI
Immediate Start
2.5
2.38 – 2.73
Waitlist Control
2.6
2.46 – 2.77
MEQ, 12 weeks
Group
Value
95% CI
Immediate Start
2.88
2.73 – 3.03
Waitlist Control
2.5
2.37 – 2.69
Self Efficacy: General Self-Efficacy ScaleSecondary· 12 weeks
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.
GSE, baseline
Group
Value
95% CI
Immediate Start
28.9
27.24 – 30.59
Waitlist Control
28.2
26.20 – 30.20
GSE, 12 weeks
Group
Value
95% CI
Immediate Start
32.3
30.70 – 33.91
Waitlist Control
28.2
26.49 – 29.95
OmegaScoreSecondary· 12 weeks
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.
baseline
Group
Value
95% CI
Immediate Start
3.58
± 0.74
Waitlist Control
3.43
± 0.50
week 12
Group
Value
95% CI
Immediate Start
7.18
± 2.12
Waitlist Control
3.47
± 0.92
Fasting Cholesterol PanelSecondary· 12 weeks
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.
triglycerides, baseline
Group
Value
95% CI
Immediate Start
1.13
0.93 – 1.32
Waitlist Control
1.02
0.89 – 1.15
triglycerides, week 12
Group
Value
95% CI
Immediate Start
0.88
0.69 – 1.06
Waitlist Control
0.88
0.74 – 1.03
Total cholesterol, baseline
Group
Value
95% CI
Immediate Start
4.72
4.24 – 5.19
Waitlist Control
4.80
4.30 – 5.30
Total cholesterol, week 12
Group
Value
95% CI
Immediate Start
4.62
4.11 – 5.13
Waitlist Control
4.75
4.32 – 5.18
LDL, baseline
Group
Value
95% CI
Immediate Start
2.63
2.20 – 3.05
Waitlist Control
2.84
2.42 – 3.74
LDL, week 12
Group
Value
95% CI
Immediate Start
2.67
2.21 – 3.57
Waitlist Control
2.86
2.50 – 3.21
HDL, baseline
Group
Value
95% CI
Immediate Start
1.58
1.40 – 1.75
Waitlist Control
1.50
1.34 – 1.66
HDL, week 12
Group
Value
95% CI
Immediate Start
1.55
1.37 – 1.73
Waitlist Control
1.49
1.32 – 1.67
Hemoglobin A1cSecondary· 12 weeks
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.
baseline
Group
Value
95% CI
Immediate Start
5.35
5.23 – 5.46
Waitlist Control
5.52
5.15 – 5.88
12 weeks
Group
Value
95% CI
Immediate Start
5.36
5.24 – 5.48
Waitlist Control
5.57
5.16 – 5.97
Serum Vitamin CSecondary· 12 weeks
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.
baseline
Group
Value
95% CI
Immediate Start
49.00
41.55 – 56.45
Waitlist Control
41.36
33.99 – 48.74
week 12
Group
Value
95% CI
Immediate Start
50.90
43.17 – 58.64
Waitlist Control
42.25
35.24 – 49.26
Serum Beta-caroteneSecondary· 12 weeks
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.
baseline
Group
Value
95% CI
Immediate Start
0.53
0.38 – 0.67
Waitlist Control
0.40
0.29 – 0.52
week 12
Group
Value
95% CI
Immediate Start
0.66
0.49 – 0.83
Waitlist Control
0.44
0.32 – 0.57
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Canadian College of Naturopathic Medicine
Last refreshed: 4 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05573672.