Healthy subjects
Conditions
Interventions
16-week intake of the test food
16-week intake of the placebo food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese male and female aged less than 50 years or older 80 years old at the time of the informed. 2)Male and female with Japanese nationality. 3)Subject with an MMSE score of 22 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 diagnosed as dementia. 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)ubjects who have disease or history of diabetes, liver disease(hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, and metabolic disease. 10)Subject who uses health foods, supplements, and medicines that may affect cognitive function 11)Subjects who has undergone surgery of the gastrointestinal tract(Appendicitis is excluded). 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. 14Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15)Subject who can't keep the daily records. 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 |
|---|---|
| RBANS | — |
Secondary
| Measure | Time frame |
|---|---|
| MCI screen | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed