{"id":"3b7f4419-7dd2-5c69-86ac-2f9e059ac7fd","stable_key":"d8050016-13c9-5391-9d61-63de73590053:zeaxanthin-zvf-acuity","predicate":"associated_with_improvement_in","statement":"The zeaxanthin arm showed a 1.5-line improvement in high-contrast acuity; the indexed result does not establish between-group superiority.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"bec447f4-aa36-5bcf-9a0e-f91e2d41e00d","mechanism_event_label":"A within-arm improvement is weaker evidence than a clear treatment comparison.","subject":{"id":"0a60c685-7502-5ece-9da2-2c1a2e3bcdf1","slug":"zeaxanthin","display_name":"Dietary (3R,3-prime-R)-zeaxanthin","entity_type_key":"small_molecule"},"object":{"id":"5e29c923-c50c-544b-9205-e772293477b8","slug":"zvf-high-contrast-acuity","display_name":"High-contrast visual acuity in ZVF trial","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"bec447f4-aa36-5bcf-9a0e-f91e2d41e00d","stable_key":"d8050016-13c9-5391-9d61-63de73590053:zeaxanthin-zvf-acuity-event","event_type":"observed_intervention","label":"A within-arm improvement is weaker evidence than a clear treatment comparison.","description":"The zeaxanthin arm showed a 1.5-line improvement in high-contrast acuity; the indexed result does not establish between-group superiority.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"5dd84367-3f8e-5a3f-b952-a96174ea51fa","slug":"lutein","display_name":"Lutein","entity_type_key":"small_molecule"},"role":"active_comparator_or_combination","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"0a60c685-7502-5ece-9da2-2c1a2e3bcdf1","slug":"zeaxanthin","display_name":"Dietary (3R,3-prime-R)-zeaxanthin","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"5e29c923-c50c-544b-9205-e772293477b8","slug":"zvf-high-contrast-acuity","display_name":"High-contrast visual acuity in ZVF trial","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/zeaxanthin-research/22027699.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"849b03f2bf0734e12b654e662e0a15e5f347415de7b0bbabe2cdc0d7bad85e3e\", \"start_char\": 0, \"end_char\": 3131, \"text_sha256\": \"849b03f2bf0734e12b654e662e0a15e5f347415de7b0bbabe2cdc0d7bad85e3e\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Small randomized active-comparator ZVF trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"One year; 8 mg zeaxanthin, 8 mg zeaxanthin plus 9 mg lutein, or 9 mg lutein comparator","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"The so-called faux placebo was active lutein. Small unequal arms, multiple outcomes and borderline tests limit claims of superiority; proposed competition was not directly tested.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Zeaxanthin research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"zeaxanthin","display_name":"Dietary (3R,3-prime-R)-zeaxanthin","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"60 patients with mild-to-moderate AMD; 57 men","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"A within-arm improvement is weaker evidence than a clear treatment comparison.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[zeaxanthin-p22027699] Randomized, double-blind, placebo-controlled study of zeaxanthin and visual function in patients with atrophic age-related macular degeneration: the Zeaxanthin and Visual Function Study (ZVF) FDA IND #78, 973. (2011). https://pubmed.ncbi.nlm.nih.gov/22027699/ DOI: 10.1016/j.optm.2011.08.008","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Macular pigment and visual tasks","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"fb12d7f2-04f6-5830-95cc-d0346d8b18e2","evidence_kind":"source_excerpt","locator":"Lines 990-1001","start_line":990,"end_line":1001,"excerpt":"### zeaxanthin-zvf-acuity\nThe zeaxanthin arm showed a 1.5-line improvement in high-contrast acuity; the indexed result does not establish between-group superiority.\nCondition category: normal\nnutrient_topic: Zeaxanthin research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: A within-arm improvement is weaker evidence than a clear treatment comparison.\norganism: 60 patients with mild-to-moderate AMD; 57 men\ntissue_or_cell_type: Macular pigment and visual tasks\nexperimental_model: Small randomized active-comparator ZVF trial\nlimitations: The so-called faux placebo was active lutein. Small unequal arms, multiple outcomes and borderline tests limit claims of superiority; proposed competition was not directly tested.\nexposure: One year; 8 mg zeaxanthin, 8 mg zeaxanthin plus 9 mg lutein, or 9 mg lutein comparator\nevidence_span: {\"source_cache\": \"artifacts/zeaxanthin-research/22027699.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"849b03f2bf0734e12b654e662e0a15e5f347415de7b0bbabe2cdc0d7bad85e3e\", \"start_char\": 0, \"end_char\": 3131, \"text_sha256\": \"849b03f2bf0734e12b654e662e0a15e5f347415de7b0bbabe2cdc0d7bad85e3e\"}\n[zeaxanthin-p22027699] Randomized, double-blind, placebo-controlled study of zeaxanthin and visual function in patients with atrophic age-related macular degeneration: the Zeaxanthin and Visual Function Study (ZVF) FDA IND #78, 973. (2011). https://pubmed.ncbi.nlm.nih.gov/22027699/ DOI: 10.1016/j.optm.2011.08.008","model_system":"Small randomized active-comparator ZVF trial","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [zeaxanthin-p22027699] Randomized, double-blind, placebo-controlled study of zeaxanthin and visual function in patients with atrophic age-related macular degeneration: the Zeaxanthin and Visual Function Study (ZVF) FDA IND #78, 973. 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