Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese male and female aged between 20 and 60 years old at the time of the informed. 2)Subject who feels fatigue and stress routinely. 3)Subject who fatigues score (FI-T score) of POMS 2 abbreviated version is 50 points or more. 4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1)Subject who is taking medication or under medical treatment. 2)Subject who is under exercise therapy or dietetic therapy. 3)Subject who has an allergy for test food. 4)Subject who has or had a history of either medicine or alcohol dependence syndrome. 5)Subject who has or had a history of mental illness (depression) or sleep disturbance. 6)Subject who is on a night-shift or is a shift worker. 7)Subject whose lifestyle is extremely irregular. 8)Subject who has an unbalanced diet. 9)Subject who has current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases. 10)Subjects who has taken health foods, supplements, or drugs that may affect fatigue relief. 11)Subject who has routinely taken large amounts of drinks containing a lot of caffeine (equivalent to 7 cups of coffee / day or more). 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 drawn 200mL within the past 1 months or 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 is expected to have major changes or stress in their own home environment or work environment from one month before screening to the end of the exam (job change, move, marriage, etc.). 16)Subject who gets intense exercise every day. 17)Subject who smokes regularly om a daily(more than 20 cigarettes per day). 18)Subject who can't keep the daily records. 19)Subject who is judged as an inappropriate candidate according to the screening data. 20)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS2 shorter version | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS questionnaire,Pittsburgh Sleep Quality Index,Cortisol (saliva), chromogranin A (saliva) | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed