Healthy subjects
Conditions
Interventions
4-weeks intake of the test food. Wash out (4 weeks) 4-weeks intake of the placebo food.
4-weeks intake of the placebo food. Wash out (4 weeks) 4-weeks intake of the test food.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese male and female who are between 40 and 70 years old at the time of obtaining written consent. 2.Subject who has a General Well-Being Schedule: GWBS score of 70 points or less. 3.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Habitual drinkers (subject who drinks more than once a week on average in the last 3 months). 2.Subject who plans to have a health checkup and a human dock test during the test period. 3.Subject who is taking medication or under medical treatment due to serious illness. 4.Subject who is under exercise therapy or dietetic therapy. 5.Subject who may develop allergies (alcohol) due to the test foods. 6.Subject with current or history of alcohol and drug dependence. 7.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 8.Subject with irregular life rhythms due to night shifts or shift work. 9.Subject with extremely irregular lifestyle habits such as eating and sleeping. 10.Subject who has an extremely unbalanced diet. 11.Subject who uses health foods, supplements, and medicines that affect alcohol metabolism. 12.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 14.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15.Subject who has difficulty observing records on various survey forms. 16.Subject who is judged as an inappropriate candidate according to the screening data. 17.Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General Well-Being Schedule: GWBS | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) POMS2 shortened version, Pittsburgh Sleep Quality Index, serum free testosterone, serum DHEA-S, serum cortisol, plasma ACTH (Safety evaluation) Vital signs, physical measurements, blood biochemistry, adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Public Relations Department
Outcome results
None listed