{"id":"d5dcd9d3-e490-56a1-8b8d-5d4b8255eec4","stable_key":"33bef151-bdc7-5892-aff6-0345ab149739:a-single-oral-dose-produces-plasma-immunoreactivity","predicate":"increases","statement":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h.","claim_class":"mechanistic","status":"source_derived_draft","evidence_grade":"ungraded","direction":"positive","is_public":true,"mechanism_event_id":"c620c199-93bc-5021-85a4-881de95189f3","mechanism_event_label":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h.","subject":{"id":"9910223c-2a27-5d75-8003-91d72e71be9a","slug":"nsk-sd","display_name":"NSK-SD fermented soybean extract","entity_type_key":"chemical_species"},"object":{"id":"9d6038d5-8903-592d-9899-47ed9f3de183","slug":"nattokinase-immunoreactive-plasma-material","display_name":"Plasma nattokinase-immunoreactive material","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"c620c199-93bc-5021-85a4-881de95189f3","stable_key":"33bef151-bdc7-5892-aff6-0345ab149739:a-single-oral-dose-produces-plasma-immunoreactivity-event","event_type":"observed_intervention","label":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h.","description":"Serum","status":"provisional","compartment":null,"participants":[{"entity":{"id":"9910223c-2a27-5d75-8003-91d72e71be9a","slug":"nsk-sd","display_name":"NSK-SD fermented soybean extract","entity_type_key":"chemical_species"},"role":"acting component","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"9d6038d5-8903-592d-9899-47ed9f3de183","slug":"nattokinase-immunoreactive-plasma-material","display_name":"Plasma nattokinase-immunoreactive material","entity_type_key":"cellular_process"},"role":"component the finding is about","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"duration","value_text":"Single dose, sampling to 48 h","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_access","value_text":"Primary PubMed abstract and indexed metadata reviewed. Full-text method details not stated here remain unresolved.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Human (11 healthy adults, 5 male and 6 female, ages 21-65)","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"NSK-SD softgel, 2,000 FU, about 100 mg","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"No control group and a non-validated polyclonal rabbit anti-nattokinase capture ELISA. EFSA reviewed this study and noted the same limitations, adding that it did not assess the biological activity of nattokinase in blood. The authors themselves recommend that future work look separately for intact enzyme and for bioactive peptides.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"organism","value_text":"Human (11 healthy adults, 5 male and 6 female, ages 21-65)","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"A pilot study on the serum pharmacokinetics of nattokinase in humans following a single, oral, daily dose. (2013) https://pubmed.ncbi.nlm.nih.gov/23709455/","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"route","value_text":"In vivo, oral","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue","value_text":"Serum","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"219b6cf7-db2a-539d-bb4d-3aa45cfb51cb","evidence_kind":"source_excerpt","locator":"Lines 818-818","start_line":818,"end_line":818,"excerpt":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h.","model_system":"Human (11 healthy adults, 5 male and 6 female, ages 21-65)","directness":"reported_statement","verification_status":"source_derived_draft","notes":"","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"41cb127c-1c23-53aa-b7d0-5ec7f6fa3c99","stable_key":"import-33bef151-bdc7-5892-aff6-0345ab149739","title":"Nattokinase: what the purified enzyme cleaves, what survives being eaten, and the gap between the two (2026-09-23)","document_type":"imported_text","citation_label":"Original AI-assisted curation built from a supplied entity-first document of 105 entities and 129 claims. Every reference in that document was resolved against live PubMed with its abstract read and its DOI cross-checked on 2026-09-23, and the EFSA novel-food opinion was retrieved and read in full. That check corrected two PMIDs that pointed at unrelated papers, two DOIs, and two papers recorded as carrying no erratum that do carry one; it also reversed three findings the supplied document had stated backwards. Two papers carry a published correction, recorded as such and not as a retraction. Three sources are not indexed in PubMed and are cited by what they have. Laboratory lineages are recorded, so the four papers from one group, the three from another and the two readings of a single applicant dossier cannot be counted as separate lines of support. Study-specific doses, units, populations and limitations retained; activity units are never converted between systems. Not publisher full text.","file_path":"","sha256":"34fc46e0e849d06bfa13cb099a79b50679dd6fd0de8a5a0575326afdde3259c1","revision_id":"efd063e6-e982-5f6e-a4b8-6f2ffe4185ce","review_status":"unverified_draft","notes":""}}],"relations":[{"id":"4737fcc7-4c5c-5fa4-b40b-4375e73e4087","relation_type":"limits_model_validity_of","notes":"The rat experiment bypassed the stomach and had no surgical control, so it cannot stand in for ordinary oral dosing.","source_claim_id":"c168afd5-ac55-58d0-99f8-3ee1ab7413dc","source_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:intraduodenal-nattokinase-degrades-plasma-fibrinogen-in-rat","source_statement":"Nattokinase injected into a tied intestinal loop at 80 mg/kg was followed by fibrinogen degradation products in plasma in all twenty rats, with a 270 kDa fragment appearing within 0.5 to 5 h.","target_claim_id":"d5dcd9d3-e490-56a1-8b8d-5d4b8255eec4","target_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:a-single-oral-dose-produces-plasma-immunoreactivity","target_statement":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h."},{"id":"23f496c5-2651-5627-813b-5354b047c446","relation_type":"qualifies","notes":"What the assay detected is antibody-reactive material, which is not the same thing as intact active enzyme.","source_claim_id":"bca226bc-a002-50ce-8905-a7364017ad38","source_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:immunoreactive-material-is-not-shown-to-be-active-enzyme","source_statement":"A polyclonal ELISA signal does not by itself distinguish intact catalytically active nattokinase from fragments, complexes or cross-reactive material.","target_claim_id":"d5dcd9d3-e490-56a1-8b8d-5d4b8255eec4","target_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:a-single-oral-dose-produces-plasma-immunoreactivity","target_statement":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h."},{"id":"e01d94e9-c4b0-5875-8367-cc9b36aafaf1","relation_type":"qualifies","notes":"The product loses activity below pH 5.0 and fasting gastric pH is well below that, so what reaches the intestine need not be the molecule that was swallowed.","source_claim_id":"a3f5c12a-7ed8-5f62-a957-4abe60699c4e","source_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:nsk-sd-is-labile-below-ph-5","source_statement":"In product testing at 25 C, NSK-SD retained activity for 24 h between pH 5.5 and 10 but was labile below pH 5.0.","target_claim_id":"d5dcd9d3-e490-56a1-8b8d-5d4b8255eec4","target_claim_key":"33bef151-bdc7-5892-aff6-0345ab149739:a-single-oral-dose-produces-plasma-immunoreactivity","target_statement":"A single 2,000 FU oral NSK-SD dose produced anti-nattokinase immunoreactivity in serum that rose significantly from baseline between 2 and 24 h and peaked at about 13.3 +/- 2.5 h."}],"conflicts":[],"corrections":[],"research":null}