Sulforaphane for Autism

Overseen By Edward S Stenroos

Age: < 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Antibiotics

Disqualifiers: Seizure, Renal, Hepatic, Thyroid, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 18 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if sulforaphane, a compound from broccoli, can improve symptoms in males with autism. Sulforaphane boosts protective enzymes and helps manage stress and immune responses. The study aims to see improvements in social interaction, behavior, and communication. Sulforaphane, derived from broccoli sprouts, has shown potential benefits in previous trials for improving behavior and social responsiveness in individuals with autism spectrum disorder (ASD).

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

The trial information does not specify if you need to stop taking your current medications. However, if you have a current infection or are being treated with antibiotics, you may not be eligible to participate.

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. ^{1 2 3 4 5}

How does the treatment sulforaphane differ from other treatments for autism?

Sulforaphane, derived from broccoli sprouts, is unique because it targets metabolic and immunologic pathways that may improve behavior and social responsiveness in autism, unlike other treatments that do not address these core features. It is taken orally and has shown potential benefits in clinical trials, although more research is needed to confirm its effectiveness. ^{1 2 3 6 7}

Is sulforaphane an effective treatment for autism?

Some studies suggest that sulforaphane, a compound found in broccoli, may help improve behavior in people with autism, especially in older children and young adults. However, results are mixed, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Steven Buyske

Principal Investigator

Rutgers, The State University of NJ

Are You a Good Fit for This Trial?

This trial is for males aged 13-30 with a diagnosis of autistic disorder in New Jersey. Participants must have a parent or guardian's consent and be able to complete all study visits. They should not have kidney, liver, thyroid issues, current infections, recent major surgery or chronic diseases like heart disease or diabetes.

Inclusion Criteria

I am male.

Autistic disorder diagnosis

I am between 13 and 30 years old.

Exclusion Criteria

Absence of a parent or legal guardian and consent

My kidney function is impaired with a creatinine level over 1.2 mg/dl.

I am currently fighting an infection or taking antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments are conducted before treatment begins

1 week

1 visit (in-person)

Treatment

Participants receive either sulforaphane or placebo for 18 weeks

18 weeks

Visits at weeks 4, 10, and 18 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at week 22

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Sulforaphane

Trial Overview The trial is testing whether sulforaphane can improve core symptoms of autism. Sulforaphane is derived from vegetables like broccoli and will be given in controlled amounts compared to a placebo in a double-blind setup where neither the participants nor the researchers know who receives what treatment.

How Is the Trial Designed?

Group I: Sulforaphane Experimental Treatment 1 Intervention

About 30 subjects will be randomized into this arm, receiving pills with glucoraphanin rich broccoli seed powder containing active myrosinase resulting in sulforaphane once ingested Doses will be weight dependent with each pill resulting in \~ 50 µmol sulforaphane. Body weight Dose of sulforaphane 34 kg \~ 50 µmol 68 kg \~ 100 µmol 102 kg \~ 150 µmol

Group II: Placebo Placebo Group 1 Intervention

About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Rowan University

Collaborator

Trials

25

Recruited

3,000+

Published Research Related to This Trial

A new ultra-fast and accurate method was developed to measure sulforaphane (SFN) and its precursor glucoraphanin (GR) in human urine, demonstrating over 87% recovery and low variability, which is crucial for studying their effects in humans.

After consuming broccoli sprouts, participants showed up to 40% bioavailability of SFN, indicating that dietary intake of broccoli can effectively deliver this beneficial compound to the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new ultra-rapid UHPLC/MS/MS method for assessing glucoraphanin and sulforaphane bioavailability in human urine. Dominguez-Perles, R., Medina, S., Moreno, DÁ., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Sulforaphane from Broccoli Reduces Symptoms of Autism: A Follow-up Case Series from a Randomized Double-blind Study. [2022]

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

A new ultra-rapid UHPLC/MS/MS method for assessing glucoraphanin and sulforaphane bioavailability in human urine. [2021]

7. 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]