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The verification study for safety evaluation of test food overdose in humans: an open-label trial

The verification study for safety evaluation of test food overdose in humans: an open-label trial - The verification study for safety evaluation of test food overdose in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026582
Enrollment
52
Registered
2018-03-17
Start date
2017-03-17
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 or prone to be constipated

Interventions

Duration: 4 weeks Follow-up duration: 2 weeks Eat six of test foods per day any time

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese adults 2. Those who are healthy or who have 2-5 times of defecation per week 3. Those who are considered as appropriate for the study by the physician and dentist

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Those who are allergic to medicines, milk, beans, orange, and/or other food products 5 Those who are pregnant, breast-feeding, and plan to become a pregnant 6. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 7. Others considered as inappropriate for the study by the physician

Design outcomes

Primary

MeasureTime frame
1. Body measuring / Physical examination 2. Medical examination 3. Blood test 4. Urinalysis 5. Questionnaire (the Likert scale method) 6. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) 7. Bowel movement diary 8. Dental examination *Above 1-6, conduct examinations and tests at 0 week and at 2 and 4 weeks after the ingestion and at follow-up period 2 weeks *Above 7, record when defecating *Above 8, conduct examinations at 0 week and at follow-up period 2 weeks

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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