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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if sulforaphane, a compound from vegetables like broccoli, can improve core symptoms in people with autism. Participants will receive either sulforaphane or a placebo (a dummy treatment) to compare results. The study will also examine how different individuals might respond based on their body chemistry and genetics. It seeks males aged 13-30 with a diagnosed autistic disorder who haven't experienced seizures in the last two years and do not have significant kidney, liver, or thyroid issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows 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. Trials with people who have autism found that sulforaphane was mostly well-tolerated. However, some mild side effects, like stomach upset, have been reported. One study noted that two people with a history of seizures experienced seizures again, highlighting the need for careful monitoring in such cases. Overall, evidence suggests that sulforaphane is safe for most people, but individual reactions can differ. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Unlike standard autism treatments that often focus on behavioral therapy or medications like antipsychotics and stimulants, sulforaphane is unique because it's derived from broccoli seeds and offers a nutritional approach. Researchers are excited about sulforaphane because it works by potentially targeting oxidative stress and inflammation in the brain, which are not directly addressed by current medications. Additionally, sulforaphane's natural origin and its novel mechanism make it a promising alternative or complement to existing therapies, with the potential for fewer side effects.

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

Research has shown that sulforaphane, a natural compound in broccoli, might help improve symptoms of autism spectrum disorder (ASD). Studies have found that sulforaphane can lead to positive changes in behavior and communication for people with ASD. In this trial, some participants will receive sulforaphane. Previous controlled trials discovered that participants taking sulforaphane had better social interaction and verbal communication than those taking a placebo. Another study suggested that sulforaphane might boost brain chemicals that protect against stress and inflammation. Overall, current evidence suggests that sulforaphane is a promising and safe option for treating ASD symptoms. ^{1 2 6 7 8}

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. 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 ...

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

controlled study of myrosinase-enriched glucoraphanin, a ... In a randomized, controlled trial of sulforaphane for autism spectrum disorder conducted by. Singh et al. [48], 2 subjects with a history of seizures had ...

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

Therapeutic efficacy of sulforaphane in autism spectrum ... This study aimed to investigate the relationship between the effects of SFN on childhood ASD and GM through animal model and human studies.

4. 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.

5. mdpi.com mdpi.com/1420-3049/24/19/3593

Broccoli or Sulforaphane: Is It the Source or Dose That ... Other pharmacodynamic effects of interventions with glucoraphanin/sulforaphane in humans include: Increase in the levels of reduced glutathione in brain [81], ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6804255/

Broccoli or Sulforaphane: Is It the Source or Dose That ... Bioavailability of sulforaphane following ingestion of glucoraphanin-rich broccoli sprout and seed ... Sulforaphane treatment of autism spectrum disorder (ASD) ...

7. 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 ...

8. 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 ...