Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.

Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims. - Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035164

Enrollment

Registered

2018-12-07

Start date

2018-12-19

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 volunteers

Interventions

Oral ingestion of 6 packets of the test food per day for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adult males and females from 20 to 74years of age

Exclusion criteria

Exclusion criteria: Individuals meeting any of the following conditions will not be selected as study subjects: 1. Pregnant and nursing mothers 2. Individuals taking medication on a routine basis 3. Individuals with persistent diarrhea. 4. Individuals with a fruit allergy 5. Other individuals deemed unsuitable by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Hematologic test Blood biochemistry test Urine analysis Doctor's questions Adverse events Evaluate after 2 weeks and 4 weeks of ingestion.	—

Countries

Japan

Contacts

Public ContactShunji Mizobuchi

Kochi Medical School, Kochi University Clinical Nursing

mizoshun@kochi-u.ac.jp088-866-5811

Outcome results

None listed

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