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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055494
Enrollment
20
Registered
2024-09-13
Start date
2024-09-14
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

Intake of food containing flavonoids, 5-fold quantity of recommended daily intake, for 4 weeks

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy male and female between the ages of 18 and 64

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYoshimi Bansho

EP Mediate Co., Ltd. Foods Department Trial Planning Section

bansho.yoshimi189@eps.co.jp070-3023-8209

Outcome results

None listed

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