Autism Spectrum DisorderNCT04779632
Fish Oil Affects Cognition and ADHD Symptoms in Adults With Autism Spectrum Disorder
A study testing Experimental: Fish Oil and Comparator: Safflower Oil in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The prevalence of autism spectrum disorder (ASD) is rising and was estimated to have a prevalence of around 1.5% in developed countries in 2016. ASD is characterized by impairments in social interaction and repetitive behavior and is associated with executive dysfunction such as impaired working memory, inhibition… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Experimental: Fish Oil and Comparator: Safflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Dec 2019to 13 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A clinical diagnosis of ASD (Asperger's syndrome, Autistic disorder, or a not otherwise specified pervasive developmental disorder).
Who cannot join
- Supplementation with n-3 long-chain polyunsaturated fatty acids 1 mo prior to the intervention or during the intervention.
- Major changes to psychopharmacological treatment 1 mo prior to the intervention or during the intervention.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen - Department of Nutrition & Exercise
Copenhagen, Frederiksberg, 1958
About this study
Official title: Fish Oil Affects Cognition and ADHD Symptoms in Adults With Autism Spectrum Disorder: A Randomized Crossover Study
The prevalence of autism spectrum disorder (ASD) is rising and was estimated to have a prevalence of around 1.5% in developed countries in 2016. ASD is characterized by impairments in social interaction and repetitive behavior and is associated with executive dysfunction such as impaired working memory, inhibition, and flexibility. Furthermore, ASD is often associated with multiple comorbidities such as attention-deficit/hyperactivity disorder (ADHD), depression, and anxiety.
Systematic reviews and meta-analyses indicate that fish oil (FO) supplementation improves attention, impulsivity, and hyperactivity in children with ADHD and beneficial effects in adults with depression and anxiety. Some randomized trials in children with ASD have shown improvements on selected executive functions, but results from meta-analysis are inconsistent and no trial has examined the effect in adults with ASD. Furthermore, most of the previous studies have mainly assessed effects by questionnaires and no objective tests, only provided low doses (<1.5 g/d of n-3 long-chain polyunsaturated fatty acids) and none of them have examined the potential influence of comorbid ADHD, depression, or anxiety.
Read more
The aim of the study was to examine the effect of FO on sustained attention and visuospatial short-term memory memory, as well as cognitive inhibition, executive function, and core symptoms of ASD, and of ADHD, and social function in adults with ASD. In light of the shared and additive cognitive impairments in individuals with both ASD and ADHD, the hypothesis was that individuals with comorbid ADHD will show the most pronounced effects. The study furthermore aimed to examine potential interaction with depression, anxiety, and gender.
This was investigated in a randomized double-blind head-to-tail crossover trial in 26 adults with ASD, who are provided with FO and safflower oil (SO) for 4 weeks each. The subjects were examined at baseline and after each period with tests of attention and working memory (primary endpoints) as well as a test of cognitive flexibility and clinical questionnaires.
Read the detailed description
The aim of the study was to examine the effect of fish oil (FO) on sustained attention and visuospatial short-term memory memory, as well as cognitive inhibition, executive function, and core symptoms of ASD, and of ADHD, and social function in adults with ASD. In light of the shared and additive cognitive impairments in individuals with both ASD and ADHD, the hypothesis was that individuals with comorbid ADHD will show the most pronounced effects. The study furthermore aimed to examine potential interaction with depression, anxiety, and gender.
This was investigated in a 2 × 4 week randomized double-blind head-to-tail crossover study with FO and safflower oil (SO).
Participants were recruited by advertisements posted in autism-related institutions and autism forums on Facebook as well as via personal networking. The study aimed to recruit up to thirty participants and ended up with twenty six participants.
The intervention in the two periods consisted of four capsules two times per day of FO (corresponding to approximately 5,2 g/d long-chain polyunsaturated fatty acids) and SO (1.2 g/day of linoleic acid), respectively. The intervention sequences: FO → SO or SO → FO was determined by a randomization list generated by a person, who was not involved in the data collection and FO and SO capsules were packed in white containers of similar appearance in the same known excess amount of what was required for four weeks. The participants were allotted to one of the intervention sequences by ID numbers based on date and time of their first visit and were provided with the appropriate pre-ID labelled container in the beginning of each period.
The participants were examined at baseline and after each period. The assessment consisted of the following: attention (The d2 Test of Attention) and spatial working memory (Corsi Block-Tapping Test) as primary outcomes and as secondary outcomes, inhibition and flexibility (The Stroop Word-Color Test), ADHD symptoms (Conners Rating Scale), and executive and social functions assessed by the Behavioral Inventory of Executive Function and Social Responsiveness Scale, respectively. Compliance was verified by whole-blood fatty acid analysis.
- Being tested
- Experimental: Fish Oil, Comparator: Safflower Oil
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Fish OilDietary supplement
Participants are provided with fish oil capsules and asked to take 4 capsules of 1000 mg twice a day (in total 5.2 mg/day of long-chain n-3 fatty acids hereof 2400 mg of eicosapentaenoic acid and 1600 mg of docosahexaenoic acid) for 4 weeks.
Comparator: Safflower OilDietary supplement
Participants are provided with fish oil capsules and asked to take 4 capsules of 500 mg twice a day (containing ~ 3000 mg of linoleic acid) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Crossover study: Fish Oil --> Safflower Oil | Other | 4 weeks of fish oil supplementation followed by 4 weeks of safflower oil supplementation Receives: Dietary Supplement: Experimental: Fish Oil; Dietary Supplement: Comparator: Safflower Oil |
| Crossover study: Safflower Oil --> Fish Oil | Other | 4 weeks of safflower oil supplementation followed by 4 weeks of fish oil supplementation Receives: Dietary Supplement: Experimental: Fish Oil; Dietary Supplement: Comparator: Safflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in short-term spatial working memory
Total Score (based on the total number of blocks in correct runs) in Corsi Block-Tapping Test (a higher is better)
Measured: Baseline, 4 and 8 weeks
Change in attention
Total errors percent in d2-Test of Attention (d2-ToA): a measure of sustained attention
Measured: Baseline, 4 and 8 weeks
Secondary outcomes (4)
Cognitive flexibility and inhibition
Reading time for color-word card (sec and relative to word and color card) in Stroop Color \& Word Test (SCWT)
Measured: baseline, 4 and 8 weeks
ADHD symptoms
The total symptoms score in Conners' Adult ADHD Rating Scale - Short: Self Report (CAARS - S:S) (range 0-54) including the subscores for attention (range 0-26) and hyperactivity/impulsivity (range 0-26) (higher scores are worse)
Measured: baseline, 4 and 8 weeks
Executive function
The composite score in Behavioral Rating Inventory of Executive Function - Adult (BRIEF-A) (range 75-225) including the subscore for the metacognition index (range 45-135) and behavioral regulatory index (range 30-90) with focus on working memory, inhibition and flexibility from the two subscales, respectively (higher scores are worse)
Measured: baseline, 4 and 8 weeks
ASD symptoms
The total score in Social Responsiveness Scale, Second Edition - Adult, Self-Report (SRS-2-ASR) (range 0-195) including the sub-scores for social communication and interaction (range for all sub-scores combined 0-159) and the score for repetitive behaviours and restricted interests (range 0-36) (higher scores are worse)
Measured: baseline, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start10 Dec 2019
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized 2 x 4 weeks head-to-tail crossover trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Lotte Lauritzen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779632
- Sponsor's protocol ID
- D227
- Status last verified
- Mar 2021
- First submitted
- 3 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Affects Cognition and ADHD Symptoms in Adults With Autism Spectrum Disorder: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT04779632
- Acronym / sponsor ID
- D227
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of autism spectrum disorder (ASD) is rising and was estimated to have a prevalence of around 1.5% in developed countries in 2016. ASD is characterized by impairments in social interaction and repetitive behavior and is associated with executive dysfunction such as impaired working memory, inhibition, and flexibility. Furthermore, ASD is often associated with multiple comorbidities such as attention-deficit/hyperactivity disorder (ADHD), depression, and anxiety.
Systematic reviews and meta-analyses indicate that fish oil (FO) supplementation improves attention, impulsivity, and hyperactivity in children with ADHD and beneficial effects in adults with depression and anxiety. Some randomized trials in children with ASD have shown improvements on selected executive functions, but results from meta-analysis are inconsistent and no trial has examined the effect in adults with ASD. Furthermore, most of the previous studies have mainly assessed effects by questionnaires and no objective tests, only provided low doses (<1.5 g/d of n-3 long-chain polyunsaturated fatty acids) and none of them have examined the potential influence of comorbid ADHD, depression, or anxiety.
The aim of the study was to examine the effect of FO on sustained attention and visuospatial short-term memory memory, as well as cognitive inhibition, executive function, and core symptoms of ASD, and of ADHD, and social function in adults with ASD. In light of the shared and additive cognitive impairments in individuals with both ASD and ADHD, the hypothesis was that individuals with comorbid ADHD will show the most pronounced effects. The study furthermore aimed to examine potential interaction with depression, anxiety, and gender.
This was investigated in a randomized double-blind head-to-tail crossover trial in 26 adults with ASD, who are provided with FO and safflower oil (SO) for 4 weeks each. The subjects were examined at baseline and after each period with tests of attention and working memory (primary endpoints) as well as a test of cognitive flexibility and clinical questionnaires.
Detailed description
The aim of the study was to examine the effect of fish oil (FO) on sustained attention and visuospatial short-term memory memory, as well as cognitive inhibition, executive function, and core symptoms of ASD, and of ADHD, and social function in adults with ASD. In light of the shared and additive cognitive impairments in individuals with both ASD and ADHD, the hypothesis was that individuals with comorbid ADHD will show the most pronounced effects. The study furthermore aimed to examine potential interaction with depression, anxiety, and gender.
This was investigated in a 2 × 4 week randomized double-blind head-to-tail crossover study with FO and safflower oil (SO).
Participants were recruited by advertisements posted in autism-related institutions and autism forums on Facebook as well as via personal networking. The study aimed to recruit up to thirty participants and ended up with twenty six participants.
The intervention in the two periods consisted of four capsules two times per day of FO (corresponding to approximately 5,2 g/d long-chain polyunsaturated fatty acids) and SO (1.2 g/day of linoleic acid), respectively. The intervention sequences: FO → SO or SO → FO was determined by a randomization list generated by a person, who was not involved in the data collection and FO and SO capsules were packed in white containers of similar appearance in the same known excess amount of what was required for four weeks. The participants were allotted to one of the intervention sequences by ID numbers based on date and time of their first visit and were provided with the appropriate pre-ID labelled container in the beginning of each period.
The participants were examined at baseline and after each period. The assessment consisted of the following: attention (The d2 Test of Attention) and spatial working memory (Corsi Block-Tapping Test) as primary outcomes and as secondary outcomes, inhibition and flexibility (The Stroop Word-Color Test), ADHD symptoms (Conners Rating Scale), and executive and social functions assessed by the Behavioral Inventory of Executive Function and Social Responsiveness Scale, respectively. Compliance was verified by whole-blood fatty acid analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 2 x 4 weeks head-to-tail crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Crossover study: Fish Oil --> Safflower Oil | Other | Dietary Supplement: Experimental: Fish Oil, Dietary Supplement: Comparator: Safflower Oil4 weeks of fish oil supplementation followed by 4 weeks of safflower oil supplementation |
| Crossover study: Safflower Oil --> Fish Oil | Other | Dietary Supplement: Experimental: Fish Oil, Dietary Supplement: Comparator: Safflower Oil4 weeks of safflower oil supplementation followed by 4 weeks of fish oil supplementation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A clinical diagnosis of ASD (Asperger's syndrome, Autistic disorder, or a not otherwise specified pervasive developmental disorder).
Key exclusion criteria (2 listed)
- Supplementation with n-3 long-chain polyunsaturated fatty acids 1 mo prior to the intervention or during the intervention.
- Major changes to psychopharmacological treatment 1 mo prior to the intervention or during the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Fish OilParticipants are provided with fish oil capsules and asked to take 4 capsules of 1000 mg twice a day (in total 5.2 mg/day of long-chain n-3 fatty acids hereof 2400 mg of eicosapentaenoic acid and 1600 mg of docosahexaenoic acid) for 4 weeks. | Dietary supplement | Crossover study: Fish Oil --> Safflower Oil, Crossover study: Safflower Oil --> Fish Oil |
| Comparator: Safflower OilParticipants are provided with fish oil capsules and asked to take 4 capsules of 500 mg twice a day (containing ~ 3000 mg of linoleic acid) for 4 weeks. | Dietary supplement | Crossover study: Fish Oil --> Safflower Oil, Crossover study: Safflower Oil --> Fish Oil |
Primary outcome
Change in short-term spatial working memory
Time frame: Baseline, 4 and 8 weeks
Total Score (based on the total number of blocks in correct runs) in Corsi Block-Tapping Test (a higher is better)
Change in attention
Time frame: Baseline, 4 and 8 weeks
Total errors percent in d2-Test of Attention (d2-ToA): a measure of sustained attention
4 secondary outcomes
Cognitive flexibility and inhibition
Time frame: baseline, 4 and 8 weeks
ADHD symptoms
Time frame: baseline, 4 and 8 weeks
Executive function
Time frame: baseline, 4 and 8 weeks
ASD symptoms
Time frame: baseline, 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Fish Oil and Comparator: Safflower Oil in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 2 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 3 Mar 2021. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in short-term spatial working memory (time frame: Baseline, 4 and 8 weeks). 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?
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 3 Mar 2021.