{"id":"ca8a077b-eb94-5fa0-9314-d30fa20e2035","stable_key":"44eaeae5-557a-552b-8998-884f30462e2a:sulforaphane-autism-primary-null","predicate":"did_not_significantly_improve","statement":"The primary OACIS comparison did not significantly differ between active and placebo groups at seven or 15 weeks.","claim_class":"mechanistic","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"4995996b-2c18-5237-aa33-f236737ecf2f","mechanism_event_label":"The main outcome did not confirm the hoped-for benefit.","subject":{"id":"367b5d3e-6202-538d-9c94-69b981089460","slug":"glucoraphanin-myrosinase-preparation","display_name":"Glucoraphanin plus active myrosinase preparation","entity_type_key":"chemical_species"},"object":{"id":"03be4d45-fa6f-5a06-b7fa-ad6a4021bb8f","slug":"autism-oacis-score","display_name":"Ohio Autism Clinical Impressions Scale primary outcome","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"4995996b-2c18-5237-aa33-f236737ecf2f","stable_key":"44eaeae5-557a-552b-8998-884f30462e2a:sulforaphane-autism-primary-null-event","event_type":"biochemical_relationship","label":"The main outcome did not confirm the hoped-for benefit.","description":"The primary OACIS comparison did not significantly differ between active and placebo groups at seven or 15 weeks.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"367b5d3e-6202-538d-9c94-69b981089460","slug":"glucoraphanin-myrosinase-preparation","display_name":"Glucoraphanin plus active myrosinase preparation","entity_type_key":"chemical_species"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"03be4d45-fa6f-5a06-b7fa-ad6a4021bb8f","slug":"autism-oacis-score","display_name":"Ohio Autism Clinical Impressions Scale primary outcome","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/sulforaphane-research/34034808.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1b60b5ce85bab14b43239e810410dd230703600eac55bc8960c621ae7de881a4\", \"start_char\": 0, \"end_char\": 3223, \"text_sha256\": \"1b60b5ce85bab14b43239e810410dd230703600eac55bc8960c621ae7de881a4\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Randomized double-blind trial followed by open-label and withdrawal phases","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Glucoraphanin plus active myrosinase tablets, not preformed sulforaphane; 15 weeks randomized, 15 weeks open-label, six weeks off","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Primary endpoint was nonsignificant. The published correction (PMID 34134777, DOI 10.1186/s13229-021-00451-9) clarifies the preparation: 34 micromol glucoraphanin per tablet, calculated to yield about 15 micromol sulforaphane. Open-label analyses are nonrandomized.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Sulforaphane research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"sulforaphane","display_name":"Sulforaphane / SFN, stereochemistry specified per study","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Human, 57 children aged 3-12 randomized; 45 analyzed","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The main outcome did not confirm the hoped-for benefit.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[sulforaphane-p34034808] Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder. (2021). https://pubmed.ncbi.nlm.nih.gov/34034808/ DOI: 10.1186/s13229-021-00447-5","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Primary OACIS and secondary caregiver ratings","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"836d1386-590c-5fde-8827-4d6a8adaf27a","evidence_kind":"source_excerpt","locator":"Lines 1360-1371","start_line":1360,"end_line":1371,"excerpt":"### sulforaphane-autism-primary-null\nThe primary OACIS comparison did not significantly differ between active and placebo groups at seven or 15 weeks.\nCondition category: normal\nnutrient_topic: Sulforaphane research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: The main outcome did not confirm the hoped-for benefit.\norganism: Human, 57 children aged 3-12 randomized; 45 analyzed\ntissue_or_cell_type: Primary OACIS and secondary caregiver ratings\nexperimental_model: Randomized double-blind trial followed by open-label and withdrawal phases\nlimitations: Primary endpoint was nonsignificant. The published correction (PMID 34134777, DOI 10.1186/s13229-021-00451-9) clarifies the preparation: 34 micromol glucoraphanin per tablet, calculated to yield about 15 micromol sulforaphane. Open-label analyses are nonrandomized.\nexposure: Glucoraphanin plus active myrosinase tablets, not preformed sulforaphane; 15 weeks randomized, 15 weeks open-label, six weeks off\nevidence_span: {\"source_cache\": \"artifacts/sulforaphane-research/34034808.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1b60b5ce85bab14b43239e810410dd230703600eac55bc8960c621ae7de881a4\", \"start_char\": 0, \"end_char\": 3223, \"text_sha256\": \"1b60b5ce85bab14b43239e810410dd230703600eac55bc8960c621ae7de881a4\"}\n[sulforaphane-p34034808] Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder. 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