Trial Outcomes & Findings for Fatty Acid Supplementation in Children With ASD (Study 2) (NCT NCT04312932)

Results Overview

Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

Baseline to 90 days post randomization.

Results posted on

2025-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	GLA + EPA + DHA Group 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Overall Study STARTED	48	50
Overall Study COMPLETED	45	46
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fatty Acid Supplementation in Children With ASD (Study 2)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 90 days post randomization.

Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite Baseline	115.5 raw score on a scale Standard Deviation 32.5	106.5 raw score on a scale Standard Deviation 34.6
Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite 90 days post randomization (End of Trial)	98.1 raw score on a scale Standard Deviation 34.1	91.4 raw score on a scale Standard Deviation 36.1

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization (End of Trial)

Change in adaptive behavior composite score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-634.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite Baseline	280.3 raw score on a scale Standard Deviation 99.89	277.1 raw score on a scale Standard Deviation 114.8
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite 90 days post randomization (End of Trial)	303.6 raw score on a scale Standard Deviation 116.9	290.0 raw score on a scale Standard Deviation 120.3

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

Change in PDDBI Aggressiveness Problems raw score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness raw scores range from 0-60; higher scores are indicative of more aggressiveness.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems Baseline	26.7 raw score on a scale Standard Deviation 13.2	26.5 raw score on a scale Standard Deviation 13.8
Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems 90 days post randomization (End of Trial)	23.1 raw score on a scale Standard Deviation 12.6	23.8 raw score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Preschool Language Scales - 5 (PLS-5) Auditory Comprehension 90 days post randomization (End of Trial)	30.3 raw score on a scale Standard Deviation 14.9	30.3 raw score on a scale Standard Deviation 13.8
Preschool Language Scales - 5 (PLS-5) Auditory Comprehension Baseline	29.4 raw score on a scale Standard Deviation 14.3	28.9 raw score on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Childhood Autism Rating Scale (CARS2) (2nd ed.) 90 days post randomization (End of Trial)	32.4 raw score on a scale Standard Deviation 7.5	31.5 raw score on a scale Standard Deviation 7.8
Childhood Autism Rating Scale (CARS2) (2nd ed.) Baseline	32.9 raw score on a scale Standard Deviation 8.1	30.9 raw score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

The Autism Impact Measure is a newly developed instrument for measuring change in Autism Spectrum Disorder related behaviors. (Houghton, Journal of Autism and Developmental Disorders, 2019). The Autism Impact Measure (AIM) Total Score represents the overall level of autism symptom impact across all measured domains, incorporating both the frequency and impact of symptoms. The possible range of raw scores for the AIM Total is 41 to 410. This scale measures the global severity and pervasiveness of autism-related behaviors, with higher scores indicating greater symptom impact and worse functioning, and lower scores reflecting fewer symptoms and better functioning.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Autism Impact Measure - Total 90 days post randomization (End of Trial)	207.9 score on a scale Standard Deviation 50.6	200.0 score on a scale Standard Deviation 55.7
Autism Impact Measure - Total Baseline	222.4 score on a scale Standard Deviation 45.5	215.6 score on a scale Standard Deviation 55.5

SECONDARY outcome

Timeframe: Baseline (day 0) to end of trial (90 days)

Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Preschool Language Scales-5 Expressive Communication baseline day 0	31.0 raw score on a scale Standard Deviation 11.5	28.8 raw score on a scale Standard Deviation 10.5
Preschool Language Scales-5 Expressive Communication end of trial day 90	31.2 raw score on a scale Standard Deviation 12.2	30.7 raw score on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: Baseline (day 0) to end of trial (90 days)

Changes in Total Language raw score (sum of Auditory Comprehension and Expressive Communication raw scores). Higher scores represent better communication ability. Raw scores range 0-131.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Preschool Language Scales-5 Total Language baseline day 0	60.4 raw score on a scale Standard Deviation 25.3	57.6 raw score on a scale Standard Deviation 23.2
Preschool Language Scales-5 Total Language end of trial day 90	61.5 raw score on a scale Standard Deviation 26.6	61.0 raw score on a scale Standard Deviation 25.2

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

The Autism Impact Measure (AIM) Repetitive Behavior Score assesses repetitive movements, rituals, and restricted interests, capturing both how often these behaviors occur and how much they affect daily life. The possible range of raw scores for this scale is 16 to 80. It measures the frequency and impact of repetitive behaviors, with higher scores reflecting more frequent and disruptive behaviors and poorer functioning.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Autism Impact Measure - Restricted Behavior 90 days post randomization (End of Trial)	40.3 score on a scale Standard Deviation 12.4	38.3 score on a scale Standard Deviation 12.3
Autism Impact Measure - Restricted Behavior Baseline	43.3 score on a scale Standard Deviation 11.3	43 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

The Autism Impact Measure (AIM) Communication Score evaluates expressive and receptive communication skills, taking into account both the frequency of communication challenges and their impact on functioning. The possible range of raw scores for this scale is 12 to 60. It measures how effectively an individual communicates, with higher scores indicating greater communication difficulties and worse functioning.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Autism Impact Measure - Communication Baseline	36.4 score on a scale Standard Deviation 11.1	37.1 score on a scale Standard Deviation 10.1
Autism Impact Measure - Communication 90 days post randomization (End of Trial)	32.9 score on a scale Standard Deviation 11.4	35.4 score on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

The Autism Impact Measure (AIM) Atypical Behavior Score captures unusual sensory responses, emotional regulation difficulties, and other atypical behaviors, assessing both how often these behaviors occur and how much they interfere with daily life. The possible range of raw scores for this scale is 12 to 60. It measures the presence and impact of atypical behaviors, with higher scores indicating more frequent or intense atypical behaviors and poorer functioning.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Autism Impact Measure - Atypical Behavior Baseline	30.2 score on a scale Standard Deviation 9.6	29.5 score on a scale Standard Deviation 9.4
Autism Impact Measure - Atypical Behavior 90 days post randomization (End of Trial)	28.7 score on a scale Standard Deviation 9.5	26 score on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

The Autism Impact Measure (AIM) Social Reciprocity Score assesses social engagement, emotional responsiveness, and reciprocal interactions, considering both the frequency and impact of social difficulties. The possible range of raw scores for this scale is 10 to 50. It measures social responsiveness and connectedness, with higher scores indicating greater social difficulty and worse functioning.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Autism Impact Measure - Social Reciprocity Baseline	26.8 score on a scale Standard Deviation 6.2	25.5 score on a scale Standard Deviation 7.9
Autism Impact Measure - Social Reciprocity 90 days post randomization (End of Trial)	25.4 score on a scale Standard Deviation 7	24.3 score on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization.

The Autism Impact Measure (AIM) Peer Interaction Score evaluates social interest, initiation, and quality of interactions with peers, capturing both how often behaviors occur and how impactful they are. The possible range of raw scores for this scale is 8 to 40. It measures the child's ability to interact appropriately with peers, with higher scores indicating more challenges in peer relationships and worse functioning. for this scale is 10 to 50. Higher scores indicating greater social difficulty and worse functioning.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Autism Impact Measure - Peer Interaction 90 days post randomization (End of Trial)	25.4 score on a scale Standard Deviation 7	24.3 score on a scale Standard Deviation 8.4
Autism Impact Measure - Peer Interaction Baseline	26.8 score on a scale Standard Deviation 6.2	25.5 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization (End of Trial)

Change in communication score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-148.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication Baseline	74.2 raw score on a scale Standard Deviation 39.4	67.9 raw score on a scale Standard Deviation 39.6
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication 90 days post randomization (End of Trial)	80 raw score on a scale Standard Deviation 42.6	73.4 raw score on a scale Standard Deviation 39.4

SECONDARY outcome

Timeframe: Baseline to 90 days post randomization (End of Trial)

Change in socialization score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-174.

Outcome measures

Outcome measures
Measure	GLA + EPA + DHA Group n=45 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=43 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization Baseline	64.4 raw score on a scale Standard Deviation 30	66.1 raw score on a scale Standard Deviation 34.8
Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization 90 days post randomization (End of Trial)	67.9 raw score on a scale Standard Deviation 31.8	68.5 raw score on a scale Standard Deviation 35.8

Adverse Events

GLA + EPA + DHA Group

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Canola Oil Group

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Sarah Keim

Nationwide Children's Hospital

Phone: 614-722-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	GLA + EPA + DHA Group n=48 Participants 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 Participants Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.	Total n=96 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical <=18 years	48 Participants n=10 Participants	48 Participants n=10 Participants	96 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Female	11 Participants n=10 Participants	11 Participants n=10 Participants	22 Participants n=20 Participants
Sex: Female, Male Male	37 Participants n=10 Participants	37 Participants n=10 Participants	74 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=10 Participants	4 Participants n=10 Participants	7 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=10 Participants	44 Participants n=10 Participants	89 Participants n=20 Participants
Race (NIH/OMB) Asian	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	11 Participants n=10 Participants	9 Participants n=10 Participants	20 Participants n=20 Participants
Race (NIH/OMB) White	28 Participants n=10 Participants	28 Participants n=10 Participants	56 Participants n=20 Participants
Race (NIH/OMB) More than one race	5 Participants n=10 Participants	9 Participants n=10 Participants	14 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment United States	48 participants n=10 Participants	48 participants n=10 Participants	96 participants n=20 Participants

Measure	GLA + EPA + DHA Group n=48 participants at risk 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days	Canola Oil Group n=48 participants at risk Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.
Psychiatric disorders Sleep	39.6% 19/48 • Number of events 20 • 90 days Safety Monitoring Uniform Report Form (SMURF)	22.9% 11/48 • Number of events 12 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Respiratory, thoracic and mediastinal disorders Chest or breathing	52.1% 25/48 • Number of events 42 • 90 days Safety Monitoring Uniform Report Form (SMURF)	52.1% 25/48 • Number of events 41 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Ear and labyrinth disorders Ears	16.7% 8/48 • Number of events 8 • 90 days Safety Monitoring Uniform Report Form (SMURF)	8.3% 4/48 • Number of events 5 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Metabolism and nutrition disorders Energy level	20.8% 10/48 • Number of events 10 • 90 days Safety Monitoring Uniform Report Form (SMURF)	12.5% 6/48 • Number of events 6 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Eye disorders Eyes	0.00% 0/48 • 90 days Safety Monitoring Uniform Report Form (SMURF)	2.1% 1/48 • Number of events 1 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Renal and urinary disorders Genitourinary	2.1% 1/48 • Number of events 1 • 90 days Safety Monitoring Uniform Report Form (SMURF)	2.1% 1/48 • Number of events 1 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Gastrointestinal disorders Gastrointestinal and eating	75.0% 36/48 • Number of events 63 • 90 days Safety Monitoring Uniform Report Form (SMURF)	77.1% 37/48 • Number of events 77 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Nervous system disorders Headache	4.2% 2/48 • Number of events 2 • 90 days Safety Monitoring Uniform Report Form (SMURF)	2.1% 1/48 • Number of events 1 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Cardiac disorders Heart	4.2% 2/48 • Number of events 2 • 90 days Safety Monitoring Uniform Report Form (SMURF)	0.00% 0/48 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Infections and infestations Infection	29.2% 14/48 • Number of events 18 • 90 days Safety Monitoring Uniform Report Form (SMURF)	29.2% 14/48 • Number of events 15 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Injury, poisoning and procedural complications Injury	4.2% 2/48 • Number of events 2 • 90 days Safety Monitoring Uniform Report Form (SMURF)	6.2% 3/48 • Number of events 3 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Skin and subcutaneous tissue disorders Mouth lips teeth	4.2% 2/48 • Number of events 2 • 90 days Safety Monitoring Uniform Report Form (SMURF)	0.00% 0/48 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Musculoskeletal and connective tissue disorders Musculoskeletal and movement	6.2% 3/48 • Number of events 3 • 90 days Safety Monitoring Uniform Report Form (SMURF)	2.1% 1/48 • Number of events 1 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Respiratory, thoracic and mediastinal disorders Nose, sinus, throat	12.5% 6/48 • Number of events 7 • 90 days Safety Monitoring Uniform Report Form (SMURF)	27.1% 13/48 • Number of events 15 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Psychiatric disorders Psychological	60.4% 29/48 • Number of events 46 • 90 days Safety Monitoring Uniform Report Form (SMURF)	54.2% 26/48 • Number of events 47 • 90 days Safety Monitoring Uniform Report Form (SMURF)
Skin and subcutaneous tissue disorders Skin or hair	16.7% 8/48 • Number of events 10 • 90 days Safety Monitoring Uniform Report Form (SMURF)	18.8% 9/48 • Number of events 11 • 90 days Safety Monitoring Uniform Report Form (SMURF)