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Safety assessment study of continuous intake of plant extract containing food

Safety assessment study of continuous intake of plant extract containing food - Safety assessment study of plant extract containing food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032394
Enrollment
10
Registered
2019-05-20
Start date
2018-04-28
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

Continuous intake of test food for 7 days

Sponsors

Soiken Inc.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Healthy males whose age of 45 years or more and 64 years or less 2)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects who take anticholinergic drug, acetylcholinesterase inhibitor, or cholinergic agonist 3) Subjects who have the possibility of developing allergic symptoms by the test food 4) Subjects who are taking part in another clinical study when starting of the present study 5)Subjects having blood sample of over 200 ml within 1 month, or over 400 ml within 3 months prior to the start of the present study (e.g. donated blood) 6) Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Safety evaluation index (blood test, urine test, physical examination, medical interview)

Countries

Japan

Contacts

Public ContactTomohiro Sugino

Soiken Inc. Representative Director

sugino@soiken.com06-6871-8888

Outcome results

None listed

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