Sulforaphane for Autism Spectrum Disorder

Overseen By Elizabeth B Torres, PhD

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Antibiotics

Disqualifiers: Seizure, Kidney, Liver, Thyroid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the research is to determine if changes seen during sulforaphane treatment (a compound that comes from eating certain vegetables) can better be understood using digital biomarkers. These digital biomarkers are things like heart rate, muscle movement etc. and are measured using non-invasive devices (like a watch) and are aimed at complementing the traditional clinical scores already in use in current trials (e.g. Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS) and Ohio Autism Clinical Impressions Scale (OACIS)).

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently taking antibiotics or have a chronic medical disorder, you may not be eligible to participate.

What evidence supports the effectiveness of the treatment sulforaphane for Autism Spectrum Disorder?

Some studies suggest that sulforaphane, a compound found in broccoli, may improve behavior and cognitive function in people with Autism Spectrum Disorder (ASD). In particular, a larger clinical trial showed significant improvements in clinician-rated scales, with one-third of participants experiencing a notable decrease in symptoms after 12 weeks of treatment. ^{1 2 3 4 5}

Is sulforaphane safe for humans?

Sulforaphane, derived from broccoli, has been shown to be safe and well-tolerated in clinical trials involving children and young adults with autism spectrum disorder. ^{2 3 4 5 6}

How is sulforaphane treatment unique for autism spectrum disorder?

Sulforaphane, a compound found in broccoli, is unique for autism treatment because it mimics the effects of fever, which can temporarily improve autism symptoms, by affecting metabolic and immune pathways. Unlike other treatments, it is derived from a natural source and has shown potential benefits in behavior and cognitive function with minimal side effects. ^{1 3 4 5 7}

Eligibility Criteria

This trial is for males aged 13-30 with a diagnosis of autistic disorder who previously participated in clinical trial NCT02677051. It's not for those using broccoli extracts post-trial, without guardian consent, unable to commit to the study schedule, or with recent seizures, kidney/liver/thyroid disease, infections, antibiotics use, or major surgery within 3 months.

Inclusion Criteria

I am between 13 and 30 years old.

Autistic disorder diagnosis

Participated in clinical trial NCT02677051

Exclusion Criteria

I have had a seizure in the last 2 years.

I have been taking Avmacol or similar broccoli extracts since my last study.

I can attend all study visits and follow the treatment plan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1.47umol/kg/day sulforaphane for 12 weeks. Digital biomarkers are measured using non-invasive devices.

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measures assessed at Week 16.

4 weeks

Treatment Details

Interventions

• Sulforaphane

Trial Overview The study tests if sulforaphane treatment effects on Autism Spectrum Disorder can be tracked using digital biomarkers like heart rate and muscle movement. These are measured non-invasively and aim to enhance traditional clinical scores used in autism research.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal.

Sulforaphane is already approved in United States for the following indications:

Approved in United States as Avmacol ES for:

• None approved; used in clinical trials for various conditions including chronic kidney disease and prevention of age-associated cardiac and vascular dysfunction

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Sulforaphane treatment for autism spectrum disorder: A systematic review. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Sulforaphane Treatment in Children with Autism: A Prospective Randomized Double-Blind Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Sulforaphane in Treatment of Children with Autism Spectrum Disorder: A Randomized Double-Blind Placebo-Controlled Multi-center Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane treatment of autism spectrum disorder (ASD). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Identification of urinary metabolites that correlate with clinical improvements in children with autism treated with sulforaphane from broccoli. [2021]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Sulforaphane Treatment of Young Men with Autism Spectrum Disorder. [2021]