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: an open-label 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-UMIN000046153

Enrollment

Registered

2022-04-11

Start date

2021-11-24

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: Capsule containing carotenoid Administration: Take 14 capsules with water at any time during the day *If you forget to take the test food, take it as soon as you r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. 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. Subjects 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 take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medications and/or the test-food-related products (particularly gelatin) 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
1. Incidence of side effects 2. Incidence of adverse events	—

Secondary

Measure	Time frame
1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr) 2. Physical measurement 3. Urinalysis 4. Blood test 5. The measured values and amount of change from Scr in each of the following items at four weeks after consumption (4w): visual acuity, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass, lean body mass, muscle mass, and body water *Whole body, right arm, left arm, right leg, left leg, and trunk	—

Measure

Time frame

1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr) 2. Physical measurement 3. Urinalysis 4. Blood test 5. The measured values and amount of change from Scr in each of the following items at four weeks after consumption (4w): visual acuity, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass*, lean body mass, muscle mass*, and body water *Whole body, right arm, left arm, right leg, left leg, and trunk

—

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