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Safety evaluation of excessive intake of supplements containing plant extract

Safety evaluation of excessive intake of supplements containing plant extract - Safety evaluation of excessive intake of supplements containing plant extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052312
Enrollment
20
Registered
2023-09-27
Start date
2023-10-11
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 adults

Interventions

Intake of the supplement containing plant extract, 5-fold quantity of recommended daily intake, for 4 weeks

Sponsors

FANCL Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women between the ages of 20 and 64 at the time of obtaining informed consent 2. Subjects who fully understand the objective and content of the study and voluntarily agree to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Subjects who are judged as unsuitable for this study by the investigational doctor based on the results of clinical examination or cardiopulmonary abnormality 2. Subjects who may be at risk of developing allergies in relation to the study 3. Subjects who have a disease requiring habitual medication, subjects with a disease under treatment (excluding dry eye and dental caries treatment), and persons with a history of a serious disease requiring medication treatment 4. Subjects whose screening test physical, physical examination and clinical examination values are significantly out of the reference range 5. Subjects who are participating in other clinical studies 6. Subjects who intend to become pregnant or lactating 7. Subjects who are judged as unsuitable for the study based on the results of background survey 8. who are judged to be unsuitable as research subjects (subjects) based on the results of the screening test 9. Subjects Who judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Adverse events, physical measurement (body weight and body mass index), physical examination (blood pressure, heart rate), and laboratory tests (hematology test, blood biochemistry test, urine test)

Countries

Japan

Contacts

Public ContactKei Yasui

EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section 2

yasui.kei475@eps.co.jp080-7710-1158

Outcome results

None listed

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