Fish Oil Affects Cognition and ADHD Symptoms in Adults With Autism Spectrum Disorder

NCT04779632 | Completed

• 1 other identifier: D227
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline, 4 and 8 weeks

• Change in attention

  Total errors percent in d2-Test of Attention (d2-ToA): a measure of sustained attention

  Baseline, 4 and 8 weeks

Secondary Outcomes (4)

• Cognitive flexibility and inhibition

  baseline, 4 and 8 weeks

• ADHD symptoms

  baseline, 4 and 8 weeks

• Executive function

  baseline, 4 and 8 weeks

• ASD symptoms

  baseline, 4 and 8 weeks

Study Arms (2)

Crossover study: Fish Oil --> Safflower Oil

OTHER

4 weeks of fish oil supplementation followed by 4 weeks of safflower oil supplementation

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

Dietary Supplement: Experimental: Fish Oil; Dietary Supplement: Comparator: Safflower Oil

Interventions

Experimental: Fish Oil DIETARY_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.

Crossover study: Fish Oil --> Safflower Oil; Crossover study: Safflower Oil --> Fish Oil

Comparator: Safflower Oil DIETARY_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.

Crossover study: Fish Oil --> Safflower Oil; Crossover study: Safflower Oil --> Fish Oil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A clinical diagnosis of ASD (Asperger's syndrome, Autistic disorder, or a not otherwise specified pervasive developmental disorder).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen - Department of Nutrition & Exercise

Copenhagen, Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A person, who was not involved in the data collection generated the randomization list (online tool) and packed both types of capsules in containers of similar appearance and labeled them with ID and period. The participants were allotted to ID numbers based on date and time of their first visit and supplied with the relevant capsule container in the beginning of each period. The oil capsules were provided by two different companies and not the same size: 1 ml Eskimo-3 High 65% (Midsona Malmӧ, Sweden) and 0.75 ml SO (Natur-Drogeriet A/S, Hørning, Denmark). Containers were only handled by colleagues and participants and the investigator tried to prevent un-blinding due to differences in rattling sound by use of noise-cancelling in-ear headphones. Blinding was checked by asking the participants and the investigator to guess which oil they had received at the end of the interventions. Formal un-blinding did not occur before the primary statistical analyses was completed.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Lotte Lauritzen

Model Details: Randomized 2 x 4 weeks head-to-tail crossover trial.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 3, 2021
• Study Start: December 10, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)