A study of excessive intake of the food containing plant-derived ingredient. (SME-2019-02-FOSHUS)

A study of excessive intake of the food containing plant-derived ingredient. (SME-2019-02-FOSHUS) - A study of excessive intake of the food containing plant-derived ingredient.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037518

Enrollment

Registered

2019-07-29

Start date

2019-07-30

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

None listed

Interventions

Four weeks repeated intake of the test foods Four weeks repeated intake of the control foods

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Healthy male and female whose age are 20 <= years old <65. (2)Subjects who are able to visit medical institution on the stipulated date. (3)Subjects who are able to submit the written informed consents.

Exclusion criteria

Exclusion criteria: (1) Subjects who are with treatment. (2) Subjects whose systolic pressure <90 mmHg. (3) Females in pregnancy,lactation and scheduled pregnancy period. (4) Subjects who donated over 200ml blood components or whole blood within 4 weeks. (5) Male Subjects who donated over 400ml whole blood within 12 weeks. (6) Female who donated over 400ml whole blood within 16 weeks. (7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. (8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. (9) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks. (10) Subjects who are; (a)With present heart disorder,liver disorder,or kidney disorder. (b)With history of cardiac disorder. (c)With diabetes mellitus. (d)With allergy to drugs or foods. (e)With glaucoma. (f)With hyponatremia. (11) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. (12) Subjects who drink alcohol or smoke a lot. (13) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift. (14) Subjects who themselves or family living together work at a company that plans, researches, develops, manufactures or sells supplements and/or functional foods (including Food for Specified Health Uses). (15) Subjects who are deemed to be unsuitable by the investigator.

Design outcomes

Primary

Measure	Time frame
Expression rate of side effects	—

Countries

Japan

Contacts

Public ContactKeisuke Yasumoto

Suntory MONOZUKURI Expert Limited R&D Support Department, HE Center

Keisuke_Yasumoto@suntory.co.jp0774-66-1110

Outcome results