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Study to evaluate the safety of overconsumption of test food

Study to evaluate the safety of overconsumption of test food - Study to evaluate the safety of overconsumption of test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042950
Enrollment
12
Registered
2021-01-17
Start date
2021-01-18
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

Take 10 tablets of test food with water after breakfast

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 20 and 64 years at the time of informed consent 2. Japanese male or female 3. Participant who can input electronic diary with smartphone/PC 4. Participant who can provide written consent

Exclusion criteria

Exclusion criteria: 1. using medication or Chinese medication (except for the drugs as needed) 2. on diet / exercise therapy under the guidance of a doctor 3. history or current episode of serious diseases such as heart failure, myocardial infarction 4. history of gastrointestinal surgery (except for appendicitis) 5. taking healthy food or supplements daily 6. allergic for some drugs or food 7. participation in another clinical trial in the previous one month, currently, or during the trial. 8. pregnant or lactating, or willing to be pregnant during the trial 9. Alcohol consumption of >60g equivalent 10. heavy smoker (21 or more cigarettes /day) 11. on irregular diet, working in shift or late at night 12. donate component blood or 200ml of whole blood in the previous one month before the trial, or planning to donate blood during the trial 13. donate 400ml of whole blood in the previous three months before the trial 14. judged by the investigator to be unsuitable for participating in this study

Design outcomes

Primary

MeasureTime frame
Incidence of side effects and adverse events

Secondary

MeasureTime frame
General hematology / blood biochemistry tests, urinalysis, physiotherapy, vital signs

Countries

Japan

Contacts

Public ContactHirokuni Kayama

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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