Healthy subjects
Conditions
Interventions
Take test food on the day of the test Wash out Take placebo food on the day of the test
Take placebo food on the day of the test Wash out Take test food on the day of the test
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Japanese male aged 20 to 40 years of age at the time of the informed consent. 2)Subject with BMI>=18.5 kg/m2 and <25 kg/m2. 3)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 drinks a lot of alcohol. 2)Subject who has a smoking habit. 3)Subject who is taking medication or under medical treatment because of some serious illness. 4)Subject who is under exercise therapy or dietetic therapy. 5)Subject who has an allergy for test food. 6)Subject who has or had a history of either medicine or alcohol dependence syndrome. 7)Subject who has or had a history of mental illness (depression) or sleep disturbance. 8)Subject who is on a night-shift or is a shift worker. 9)Subject whose lifestyle is extremely irregular. 10)Subject who has an unbalanced diet. 11)Subject who is 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 uses health foods and supplements that affect lipid metabolism. 13)Subject who takes medications continuously and can not stop taking them during the study period. 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)In addition, subject who judged a study responsibility physician to be inadequate as an object of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Free fatty acid | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed