Healthy Japanese subjects
Conditions
Interventions
Duration: 2 weeks Trial food: Soft capsule containing VF extract (1 g/1 capsule) Dosage and administration: Take 2 capsules (equivalent to 2 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 sleep problems. 2. Subjects with an AIS score of 6 or higher. 3. Subjects with written consent to take part in the trial. 4. Men or women aged 20 to 65. 5. Subjects with an easy intake of capsules. 6. 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. Subjects work irregular/night/early morning shifts every day. 5. Women having the possibility or intention to become pregnant, lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of sleep quality based on the Obstructive sleep apnea syndrome (OSA) Sleep Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of sleep quality using the OSA Sleep Questionnaire for each sleep complaint on the Athens Insomnia Scale (AIS). | — |
Countries
Japan
Contacts
Public ContactMisato Ota
Kuki Sangyo Co., Ltd. R&D Medicinal Department
Outcome results
None listed