Sulforaphane for Autism

Palo Alto (17 mi)

Overseen bySteven Buyske

Age: < 65

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

Prior Safety Data

Trial Summary

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).

Eligibility Criteria

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.

I am between 13 and 30 years old.

Exclusion Criteria

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

I am currently fighting an infection or taking antibiotics.

My liver function is not more than twice the normal limit.

I am female.

I haven't had a major illness or surgery in the last 3 months.

My thyroid function is not normal.

I am willing and able to follow the study's schedule and treatments.

I am either younger than 13 or older than 30.

I have had a seizure in the last 2 years.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SulforaphaneExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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