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A safety evaluation study of excessive intake of the test food (HBF2018-02).

A safety evaluation study of excessive intake of the test food (HBF2018-02). - A safety evaluation study of excessive intake of the test food.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034658
Enrollment
44
Registered
2018-10-28
Start date
2018-10-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Four-week repeated intake of food containing the test food. Four-week repeated intake of control food not containing the test food.

Sponsors

Oneness Support Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy males and females aged 20 to 64 years-old. 2)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1)Subjects with hepatic, renal, cardiac and/or organ disorders, diabetes, and/or other serious diseases. 2)Subjects with present heart disorder, liver disorder, and/or kidney disorder. 3)Subjects with a disease currently under treatment. 4)Subjects with allergy to the study foods. 5)Subjects with anemia. 6)Subjects who play high intensity sports and/or are on a diet. 7)Subjects who play high intensity sports and/or are on a diet. 8)Subjects who are under treatment with medications (including OTC or prescribed medication). 9)Subjects who drink excessive alcohol, and/or who can't stop drinking from one day before each measurement. 10)Individuals who are a smoker. 11)Subjects who are pregnant, breast-feeding, and/or planning to become pregnant 12)Subjects who are participating in other studies and/or planning to participate during the current study period. 13)Subjects judged as unsuitable for the study by principal investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Inquiry, physical examination, and medical examination by hematology, blood biochemistry, urinalysis.

Countries

Japan

Contacts

Public ContactYuki Ishida

Hayashibara CO., LTD. R&D Division, Development Unit

yuki.ishida@hb.nagase.co.jp086-276-3141

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026