A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial

A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial - A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034423

Enrollment

Registered

2018-10-10

Start date

2018-10-10

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: 4 weeks Test food: Enzyme-treated hesperidin tablet Dose: Take 10 tablets per day Administration: Take 5 tablets after breakfast and take 5 tablets after lunch. Drink with water or lukewa

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, or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, 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 Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplement. Particularly, diosmin, anticoagulant drugs, antiplatelet drugs, antihypertensive drugs (celiprolol hydrochloride, diltiazem hydrochloride, and etc.), diazepam, central nervous system depressant, and vasodilator drugs (verapamil) 6. Subjects who are an allergic reaction to medications and/or the test food related products, particularly citrus fruit 7. Subjects who are pregnant, breast-feeding, or 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 enroll in anther clinical trial during trial period 9. Subjects who work late-night shift and the erratic lifestyle 10. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
1. Physical examination 2. Urinalysis 3. Blood test 4. Subjective symptoms (the Likert scale) * Assess these at screening (before consumption) and at 2 and 4 weeks after consumption	—

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