Investigation of promoting osteogenesis by intake of vitamin K2-rich Natto

UMIN ID: UMIN000033832

Registered date:21/08/2018

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Adult
• Date of first enrollment: 2018/08/23
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Natto

Outcome(s)

• Primary Outcome: Blood (osteocalcin)
• Secondary Outcome: Urine (Type I collagen cross-linked N- telopeptide), Urine (deoxypyridinoline), Blood (vitamin K2)

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 64years-old
• Gender: Female
• Exclude criteria: 1. Persons who has liver disease, renal disease, digestive organ disease, heart trouble, peripheral vascular disorder, a person with a history of the past that may have an influence on other final examination results or person with a history of the operation 2. Person who take warfarin 3. Persons who liver function and renal function test values show abnormalities 4. Currently, those with a disorder under treatment 5. Persons who have food or drug allergy 6. Person who suffer from anemia 7. Persons who do intense sports or are on a diet 8. Persons who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods 9. Persons who are taking healthfoods, quasi medical items, medicines (including OTC, prescription medicine) containing ingredients contained in the test food 10. Persons who consume excess alcohol or can not abstinence from the day before the test until the day 11. Persons who are pregnant, or persons who are planning to become pregnant or breastfeeding during the study period 12. Persons who are participating in the other study or planning to participate during the study period 13. Persons who judged inappropriate by the study responsible doctor for other reasons

Related Information

• Primary Sponsor: Takanofoods Co., Ltd.
• Secondary Sponsor: Miura Clinic, Medical Corporation Kanonkai Oneness Support Co., Ltd.
• Source(s) of Monetary Support: Takanofoods Co., Ltd.