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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sulforaphane, a compound found in some vegetables, can improve understanding of autism spectrum disorder. Researchers aim to determine if digital tools, such as wearable devices that track heart rate and movement, can complement traditional assessment methods. Participants will take a sulforaphane pill once daily for 12 weeks. The trial seeks males aged 13 to 30 who have been diagnosed with autistic disorder and participated in a previous related study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance understanding and treatment of autism spectrum disorder.

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.

Is there any evidence suggesting that sulforaphane is likely to be safe for humans?

Research has shown that sulforaphane, a substance in broccoli, is generally safe for people. Studies have found that products high in sulforaphane can be used safely for up to six months. Specifically, when used to help treat autism spectrum disorder (ASD), sulforaphane has very few side effects.

Participants in previous trials reported that the treatment was easy to handle, with only a few mild side effects. These results suggest that sulforaphane could be a safe choice for those considering joining a clinical trial for ASD treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Autism Spectrum Disorder, like behavioral therapies and medications, aim to manage symptoms rather than address underlying biological factors. Sulforaphane is unique because it's derived from cruciferous vegetables like broccoli and works by targeting oxidative stress and inflammation, which are thought to play a role in autism. Researchers are excited about sulforaphane because it offers a natural and potentially safer option that tackles these biological aspects, potentially improving core symptoms of autism. This treatment's novel mechanism could make it a valuable addition to existing therapeutic strategies.

What evidence suggests that sulforaphane might be an effective treatment for autism?

Research has shown that sulforaphane, a substance found in some vegetables, may help treat autism spectrum disorder (ASD). Studies have found that taking sulforaphane led to noticeable improvements in behavior. For instance, one study reported a 34% improvement in behaviors among young men with ASD. Another study noted that sulforaphane helped reduce symptoms like irritability and hyperactivity. Importantly, these benefits came with very few side effects, making sulforaphane a safe option to consider. Overall, the evidence suggests that sulforaphane could be an effective treatment for ASD. Participants in this trial will receive sulforaphane to further evaluate its effectiveness and safety. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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

I am male.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7527484/

Sulforaphane treatment for autism spectrum disorder The current evidence shows with minimal side effects observed, SFN appears to be a safe and effective treatment option for treating ASD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02909959

Sulforaphane for the Treatment of Young Men With Autism ... The study will also explore the safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its effects on challenging ...

3. pnas.org pnas.org/doi/10.1073/pnas.1416940111

Sulforaphane treatment of autism spectrum disorder (ASD) We report here that in a placebo-controlled, double-blind, randomized clinical trial, daily treatment with sulforaphane for 4–18 wk resulted in significant ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1294057/full

Therapeutic efficacy of sulforaphane in autism spectrum ... In a double-blind randomized trial with young men (aged 13–27) with ASD, SFN treatment led to significant behavioral improvements, with a 34% ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0387760425000026

Effects of sulforaphane on ABC and SRS scales in patients ... The results of this meta-analysis showed that sulforaphane significantly improved irritability and hyperactivity symptoms, suggesting that sulforaphane has the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8146218/

Randomized controlled trial of sulforaphane and metabolite ... Sulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT02909959/Prot_SAP_000.pdf

controlled study of myrosinase-enriched glucoraphanin, a ... Singh, K., et al., Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A,. 2014. 111(43): p. 15550-5. 49. Fahey, J.W., A.T. ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-1070/sulforaphane

Sulforaphane - Uses, Side Effects, and More It is possibly safe when used as medicine. Sulforaphane and sulforaphane-rich broccoli extract products have been used safely for up to 6 months. It's usually ...

9. autismparentingmagazine.com autismparentingmagazine.com/broccoli-autism-research/?srsltid=AfmBOop7MUSi-xqUl4Jlsq7yEx23feeYU1td9VteCFqybd4l27Wdj4A0

How Components in Broccoli are Advancing Autism ... A chemical produced in the body by components found in broccoli, known as sulforaphane, has demonstrated positive effects on children with autism in studies.