Healthy Japanese subjects
Conditions
Interventions
Duration:4 weeks Trial food: Soft capsule containing VF extract (1 g/1 capsule) Dosage and administration: Take 10 capsules (equivalent to 10 g of VF extract) with water 30 minutes before bedtime.
Sponsors
Nagoya City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with written consent to take part in the trial. 2. Men or women aged 20 to 65. 3. Subjects with ability to take 10 capsules daily. 4. Subjects who can complete the questionnaire via smartphone, tablet, or computer.
Exclusion criteria
Exclusion criteria: 1. Subjects currently being treated for severe renal or liver disease, heart, respiratory or endocrine disease, or other metabolic diseases. 2. Subjects currently taking medications that interfere with sleep (sleeping pills, antianxiety drugs) 3. Subjects allergic to gelatin. 4. Women having the possibility or intention to become pregnant, lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects: number and incidence of adverse effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse effects: number and incidence of adverse effects. 2. Blood pressure/pulse rate. 3. Trends in hematology, blood biochemistry and urinalysis. | — |
Countries
Japan
Contacts
Public ContactMisato Ota
Kuki Sangyo Co., Ltd. R&D Medicinal Department
Outcome results
None listed