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The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study

The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study - The verification study for safety evaluation of excessive the test food ingestion in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030421
Enrollment
40
Registered
2017-12-15
Start date
2017-12-16
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 adult people

Interventions

Duration: 4 weeks Test materials: Sea squirt-derived plasmalogen capsule {Sea squirt-derived plasmalogen: 100 mg/capsule (1 mg of plasmalogen)} Dose: 5 capsules per day Administration: Take 5 capsu

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history 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. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who take DHA or/and EPA-containing food in daily 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 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 4. Questionnaire (the Likert scale) * Assess at screening and examination before consuming and at 2 and 4 weeks after ingestion

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