Sulforaphane-rich Broccoli Sprout Extract for Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Sulforaphane-rich Broccoli Sprout Extract; Placebo
Intervention description: 30 subjects will be randomly selected to receive sulforaphane-rich Broccoli Sprout Extract. The medication will be supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane will depend on subject's body weight:
Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)
Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)
Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day); 15 subjects will be randomly selected to receive inactive placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose)
Intervention MeSH terms: Sulforaphane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Male
Minimum age: 13 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to answer whether there is evidence of measurable
      effects on social responsiveness (primary outcome) and other behavioral symptoms after
      treatment of autistic male adolescents and adults with orally administered sulforaphane-rich
      Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer
      whether treatment of male adolescents and adults with autism using orally administered
      sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity);
      treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and
      adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of
      principle).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autism diagnosis. Quantitative autism traits and severity for diagnosis of autism will
             be assessed using the ADOS-G (Modules 1-4 and Severity), Social Responsiveness Scale
             (SRS; child and adult forms), Clinical Global Impression-Severity (CGI-S) and Aberrant
             Behavior Checklist-Withdrawal subscale (ABC-W).

        Exclusion Criteria:

          -  Absence of a parent or legal guardian and consent

          -  Unavailability for all visits and adherence to study regimen

          -  Seizure within 2 years of screening

          -  Impaired renal function (serum creatinine > 1.2 mg/dl), impaired hepatic function
             (AST/ALT > 2x upper limit of normal), impaired thyroid function (TSH outside normal
             limits)

          -  Current infection or treatment with antibiotics; AND

          -  Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major
             surgery within 3 months prior to enrollment.

          -  A diagnosis of autism spectrum disorder other than autism, for example, Asperger's,
             PDD-NOS etc.