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A study to evaluate the safety of excessive consumption of the test food in humans.

Food Test - Food Test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051960
Enrollment
14
Registered
2023-08-21
Start date
2023-08-19
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 Subject

Interventions

Four-week excessive intake of test food/open study

Sponsors

Seishukai Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1,Healthy subjects, males and females, aged 20 or over, and no limit 2,Subjects who have received a sufficient explanation of the purpose and content of the research, have a clear understanding, and voluntarily express their intent to participate, can provide written consent to join the research

Exclusion criteria

Exclusion criteria: 1,Subjects currently undergoing medical treatment or therapy, including medication and traditional herbal medicine, for any form of illness or condition. 2,Subjects undergoing dietary and exercise therapy under the supervision of a doctor 3,Subjects with a current or past history of severe medical conditions. 4,Subjects who regularly consume over-the-counter pharmaceuticals, quasi-drugs, supplements, specific health-use foods, and foods with function claims. (Those who can stop taking them after obtaining consent are eligible to participate.) 5,Subjects with current or past history of medication allergies or food allergies 6,Subjects who have donated blood components or 200ml of whole blood within 1 month from the start of this study 7,Subjects who have donated 400 ml of whole blood within 4 months from the start of this study 8,Subjects who have participated or are currently participating in other clinical trials or clinical research within one month before obtaining consent, or those who plan to participate during the study period 9,Currently pregnant or breastfeeding subjects, or those who are planning to become pregnant during the study period. 10,Subject who regularly drink a lot of alchol (equivalent to 60g/day in terms of alcohol content 11,Subjects with extremely irregular eating habits, shift workers, and subjects with an irregular life rhythm, such as those working night shifts 12,Subjets who are judged by the principal investigator to be unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frame
physical examination,body weight,BMI,vital signs,clinical examination,Adverse event,Concomitant symptoms

Countries

Japan

Contacts

Public ContactTsuyoshi Takahama

Seishukai Clinic Clinical trial office

t-takahama@seishukai.or.jp0358270930

Outcome results

None listed

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