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KMID : 1161420210240080860
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Journal of Medicinal Food
2021 Volume.24 No. 8 p.860 ~ p.865
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First Clinical Trial of a Newly Developed, Low Menaquinone-7, Fermented Soybean Natto in Warfarin-Dependent Patients
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Nakajima Tomomi
Taya Yuki
Nishikawa Takanobu
Kitamura Yutaka
Kato Hideyuki
Mathis Bryan J.
Hiramatsu Yuji
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Abstract
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Bacillus subtilis fermented soybeans (natto) contain high vitamin K2 levels, mostly as menaquinone-7 (MK-7), and must be avoided by warfarin-dependent patients. This is the first report which demonstrates the characteristics and clinical relevance of a low MK-7 natto for such patients. We generated a novel, mutant B. subtilis strain TTCC2051 with short-term fermentation and reduced MK-7 production, yielding 19?24% of the normal MK-7 content. After functional assessments and a preclinical trial, 10 warfarin-dependent patients underwent a clinical trial with a 7-day ingestion test of the low MK-7 natto. Functional assessments were satisfactory, and the preclinical trial showed no increases in plasma MK-7 levels after 7 days of ingestion. In the clinical trial, 20?g/day of the low MK-7 natto significantly increased plasma MK-7 levels while 10?g/day did not. However, neither dose of low MK-7 natto changed international normalized ratio of prothrombin time (PT-INR) values in either group. The low MK-7 natto neither changed PT-INR values nor precipitated adverse events if ingested with a once-daily maximum of 20?g (46?μg of MK-7). Thus, this novel food product has potential for consumption by warfarin-dependent patients.
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KEYWORD
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menaquinone-7, natto, prothrombin time, warfarin
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