Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese male and female aged 20 to 65 years old at the time of the informed consent. 2)Subject with LDL-Cholesterol>=120mg/dL and <140mg/dL. 3)Subject without a daily exercise habit. 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 smokes a lot. 2)Subject with the diarrheal disease chronically. 3)Subject who is taking medication or under medical treatment. 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 with the bowel past surgical history,short bowel syndrome, pancreatitis, the existing illness of the biliary tract disease or history. 12)Subject with brain disease, a malignant tumor, immunologic disease, diabetes, hepatic disorder (hepatitis), renal disease, serious disease, thyroid disease, adrenal gland disease such as the heart disorder, and the like, the serious existing illness such as other metabolic disorders, and the like or the history. 13)Subject who uses a health food, a supplement affecting fat metabolism and medical supplies. 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 is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 17)Subject who can't keep the daily records. 18)Subject who is judged as an inappropriate candidate according to the screening data. 19)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-Cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| Triglyceride Total Cholesterol HDL-Cholesterol High sensitive CRP Apolipoprotein A-I Apolipoprotein B oxidized LDL | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed