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Safety evaluation study of food containing plant extract

Safety evaluation study of food containing plant extract - Safety evaluation study of food containing plant extract

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040970
Enrollment
24
Registered
2020-07-01
Start date
2020-07-01
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 test food for 12 weeks (3 tablets / day)

Sponsors

Kanazawa Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Japanese male and female over 40 years old at the time of the informed consent. 2)Subjects who do not take medication or health food continuously. 3)Subjects whose Moca-J score is ranged from 18 to 28 before intake of the test food. 4) Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to make a self-judgment, voluntarity participate in the study after understanding the content enough and agree to participate in the study by signing the written informed consent. 5) Subjects who are able to visit the hospital regularly and are able to take the test food at home.

Exclusion criteria

Exclusion criteria: 1) Subjects who have an allergy to the test food. 2) Subjecte whose GDS score is more than 10 before intake of the test food. 3)Subjects who has participated in other clinical studies (clinical trials) within 3 months before the start of the test or who is planning to participate in other clinical studies (clinical trials) during the study period. 4) Subjects who is current disease or a history of diabetes, liver disease (hepatitis), renal disease, serious diseases such as heart disease, thyroid disease, adrenal disease, or other metabolic diseases. 5)Subjects who are judged as unsuitable for the study by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Side effects and adverse events (Physical measurements, blood tests, urinalysis, vitals, doctor consultation)

Secondary

MeasureTime frame
RBMT(The Rivermead Behavioral Memory Test)

Countries

Japan

Contacts

Public ContactDaisuke Hama

Kanazawa Medical University Hospital Dementia Center

hama-d@kanazawa-med.ac.jp076-286-3511

Outcome results

None listed

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