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A verification study of safety evaluation of excessive the test food consumption in humans

A verification study of safety evaluation of excessive the test food consumption in humans: A randomized double-blind placebo-controlled trial - A verification study of safety evaluation of excessive the test food consumption in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038757
Enrollment
40
Registered
2019-12-02
Start date
2019-12-03
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 Japanese subjects

Interventions

Duration: Four weeks Test food: Tablet containing salmon nasal cartilage-derived proteoglycan Administration: Take five tablets per day after dinner with water * Daily dose should be taken within

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
1. Physical examination 2. Urinalysis 3. Blood test (hematological examination, blood biochemistry examination) * Assess the measured values at screening (before consumption) and at two and four weeks after consumption and calculate the amount of change.

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