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Safety evaluation studies of excessive ingestion of food containing isoflavone derived from the flower of the kudzu in adult men and women

Safety evaluation studies of excessive ingestion of food containing isoflavone derived from the flower of the kudzu in adult men and women - Safety evaluation studies of excessive ingestion of food containing isoflavone derived from the flower of the kudzu in adult men and women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025285
Enrollment
10
Registered
2016-12-15
Start date
2016-12-16
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

Oral ingestion of the test product 15 grains per day, 4 weeks.

Sponsors

TTC Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult males and females from 20 to 64 years of age

Exclusion criteria

Exclusion criteria: (1) Subjects who routinely use health food richly containing involvement ingredient (2) Subjects judged as unsuitable for this study 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 have participated in other clinical studies (7) Subjects who intend to become pregnant or lactating (8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (9) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/body mass index Doctor's questions Adverse event Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period

Countries

Japan

Contacts

Public ContactMai Mihara

TTC Co.,Ltd. Clinical Research Planning Department

m.mihara@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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