Trial Outcomes & Findings for Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder (NCT NCT05573672)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

8 months

Results posted on

2025-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Start Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Start n=24 Participants began intervention immediately	Waitlist n=25 Participants completed 12 week wait and then began intervention	Total n=49 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 14 • n=5 Participants	35 years STANDARD_DEVIATION 10 • n=7 Participants	37 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized East/Southeast Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized First Nations/Indigenous/Metis	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Another race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Do not know	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Beck Anxiety Inventory Score	26.2 units on a scale STANDARD_DEVIATION 8.17 • n=5 Participants	29.3 units on a scale STANDARD_DEVIATION 11.71 • n=7 Participants	27.8 units on a scale STANDARD_DEVIATION 10.1 • n=5 Participants

PRIMARY outcome

Timeframe: 8 months

Population: 443 individuals contacted the study in 8 months. Of these, 50 met criteria for enrollment

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.

Outcome measures

Outcome measures
Measure	Immediate Start n=25 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=25 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Feasibility of Participant Recruitment and Intervention Delivery	8 months	8 months

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Immediate Start n=23 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=23 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Acceptability of the Intervention by Study Participants	6.4 number of sessions attended Standard Deviation 1.5	6.4 number of sessions attended Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 weeks

Population: Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires.

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.

Outcome measures

Outcome measures
Measure	Immediate Start n=24 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=25 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Anxiety Symptom Severity: The Beck Anxiety Inventory Baseline	26.2 units on a scale Interval 22.94 to 29.48	29.3 units on a scale Interval 24.73 to 33.91
Anxiety Symptom Severity: The Beck Anxiety Inventory 12 weeks	11.0 units on a scale Interval 8.05 to 13.87	26.8 units on a scale Interval 22.09 to 31.56

SECONDARY outcome

Timeframe: 12 weeks

Population: Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires.

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.

Outcome measures

Outcome measures
Measure	Immediate Start n=24 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=25 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Diet Quality: MEDI-LITE Questionnaire Baseline	7.2 score on a scale Interval 6.32 to 8.1	7.1 score on a scale Interval 6.33 to 7.91
Diet Quality: MEDI-LITE Questionnaire 12 Weeks	10.5 score on a scale Interval 9.55 to 11.49	6.9 score on a scale Interval 6.17 to 7.74

SECONDARY outcome

Timeframe: 12 weeks

Population: Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires.

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.

Outcome measures

Outcome measures
Measure	Immediate Start n=24 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=25 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Quality of Life: PROMIS-29 v2.1 physical, baseline	4.54 score on a scale Interval 4.29 to 4.79	4.28 score on a scale Interval 3.93 to 4.63
Quality of Life: PROMIS-29 v2.1 physical, 12 weeks	4.79 score on a scale Interval 4.61 to 4.97	4.20 score on a scale Interval 3.82 to 4.56
Quality of Life: PROMIS-29 v2.1 anxiety, baseline	3.42 score on a scale Interval 3.18 to 3.65	3.55 score on a scale Interval 3.29 to 3.81
Quality of Life: PROMIS-29 v2.1 anxiety, 12 weeks	2.16 score on a scale Interval 1.81 to 2.52	3.25 score on a scale Interval 2.92 to 3.58
Quality of Life: PROMIS-29 v2.1 depression, baseline	2.59 score on a scale Interval 2.11 to 3.07	2.48 score on a scale Interval 2.03 to 2.95
Quality of Life: PROMIS-29 v2.1 depression, 12 weeks	1.72 score on a scale Interval 1.37 to 2.08	2.27 score on a scale Interval 1.83 to 2.72
Quality of Life: PROMIS-29 v2.1 fatigue, baseline	3.78 score on a scale Interval 3.45 to 4.12	3.69 score on a scale Interval 3.35 to 4.03
Quality of Life: PROMIS-29 v2.1 social, 12 weeks	3.79 score on a scale Interval 3.31 to 4.28	3.14 score on a scale Interval 2.66 to 3.62
Quality of Life: PROMIS-29 v2.1 pain, baseline	2.09 score on a scale Interval 1.59 to 2.59	2.24 score on a scale Interval 1.73 to 2.75
Quality of Life: PROMIS-29 v2.1 pain, 12 weeks	1.57 score on a scale Interval 1.19 to 1.96	2.14 score on a scale Interval 1.62 to 2.66
Quality of Life: PROMIS-29 v2.1 fatigue, 12 weeks	2.75 score on a scale Interval 2.32 to 3.18	3.53 score on a scale Interval 3.09 to 9.97
Quality of Life: PROMIS-29 v2.1 social, baseline	2.83 score on a scale Interval 2.38 to 3.28	2.81 score on a scale Interval 2.45 to 3.17

SECONDARY outcome

Timeframe: 12 weeks

Population: Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires.

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.

Outcome measures

Outcome measures
Measure	Immediate Start n=24 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=25 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Mindful Eating Behaviour: Mindful Eating Questionnaire MEQ, baseline	2.5 units on a scale Interval 2.38 to 2.73	2.6 units on a scale Interval 2.46 to 2.77
Mindful Eating Behaviour: Mindful Eating Questionnaire MEQ, 12 weeks	2.88 units on a scale Interval 2.73 to 3.03	2.5 units on a scale Interval 2.37 to 2.69

SECONDARY outcome

Timeframe: 12 weeks

Population: Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires.

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.

Outcome measures

Outcome measures
Measure	Immediate Start n=24 Participants Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation 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.	Waitlist Control n=25 Participants Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Self Efficacy: General Self-Efficacy Scale GSE, baseline	28.9 units on a scale Interval 27.24 to 30.59	28.2 units on a scale Interval 26.2 to 30.2
Self Efficacy: General Self-Efficacy Scale GSE, 12 weeks	32.3 units on a scale Interval 30.7 to 33.91	28.2 units on a scale Interval 26.49 to 29.95

SECONDARY outcome

Timeframe: 12 weeks

Population: all 50 participants assessed at baseline. 21 and 23 assessed at 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.