Healthy subjects
Conditions
Interventions
4-week intake of the test food
4-week intake of the placebo food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Japanese male and aged between 20 and 65 years old at the time of the informed. 2)Subject who feels fatigue and routinely. 3)Subject who is Beck Depression Inventory(BDI)less than 21 points. 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 who currently have a smoking habit. 8)Subject whose lifestyle is extremely irregular. 9)Subject who has an unbalanced diet. 10)Subject who regularly drink energy drinks. 11)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. 12)Subject who use stress, health foods, supplements, and medicines that affect cognitive function. 13)Subject who regularly take commercially available sleep improving drugs and sleep inducing agents. 14)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. 15)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. 16)Subject who can't keep the daily records. 17)Subject who is judged as an inappropriate candidate according to the screening data. 18)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS II (all items version),Cognitrax | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS questionnaire(6 items),Blood catecholamine 3 fraction,d-ROM,BDNF,Salivary cortisol | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed