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Safety assessment study on excessive intake of test supplement -A randomized, double blind, placebo controlled, parallel study-

Safety assessment study on excessive intake of test supplement -A randomized, double blind, placebo controlled, parallel study- - Safety assessment study on excessive intake of test supplement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033201
Enrollment
100
Registered
2018-07-01
Start date
2018-07-21
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 volunteer

Interventions

Intake of test supplement, 5-fold quantity of recommended daily intake, for 4 weeks Intake of placebo, for 4 weeks

Sponsors

FANCL Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Healthy male and female from 20 to 65 years of age

Exclusion criteria

Exclusion criteria: 1.Subjects who have judged to have problems with participation in examination due to clinical laboratory test values or cardiorespiratory abnormality 2.Subjects who are at risk of developing allergy in relation to the test supplement. 3.Subjects who have a disease requiring regular medication. Subjects who have a history of serious illness requiring medication treatment 4.Subjects whose clinical laboratory values and measured values before ingestion are significantly out of the reference range 5.Subjects who are participating in other clinical trials when start of the examination period 6.Subjects who intend to become pregnant or lactating 7.Subjects who are judged as unsuitable for the study by background survey results 8.Subjects who are judged as unsuitable for the study by the principal doctor

Design outcomes

Primary

MeasureTime frame
Safety assessment on ingestion of test supplement, 5-fold quantity of recommended daily intake, for consecutive 4 weeks.

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