Safety evaluation of excessive intake of food containing flavonoids for healthy adults.

UMIN ID: UMIN000055494

Registered date:13/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/09/14
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intake of food containing flavonoids, 5-fold quantity of recommended daily intake, for 4 weeks

Outcome(s)

• Primary Outcome: Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects who are taking health foods that mainly contain polyphenols (2) Subjects who are judged as unsuitable for this study by the principal investigator based on the results of clinical examination or cardiopulmonary abnormality (3) Subjects having possibilities for emerging allergy related to the study (4) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required (5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (6) Subjects who work in shifts or late at night and have an irregular daily rhythm (7) Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease that required medication (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects who are judged as unsuitable for the study by the investigator for other reasons

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: TOWA PHARMACEUTICAL CO.,LTD