Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese men and women whose age at the time of obtaining consent is aged older 50 to 69 years old. 2) Subject who is aware of in cognitive function (memory) decline. 3) Subject who has a MMSE-J score of 24 points or more. 4) PHQ-9 Japanese version with a score of 9 points or less. 5) Subject with an MPI score of 50.20 or higher for their MCI screen. 6) Immediate playback of MCI screen delayed playback less than the number of correct answers for the third time. 7) Non-smoker. 8) Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the study after understanding it well, and agreed to participate in the study in writing.
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 has irregular work rhythms such as working at night and shift work. 7.Subject who has extremely irregular lifestyle such as eating and sleeping. 8.Subject who has an unbalanced diet. 9.Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases. 10.Subject who uses health foods, supplements, and pharmaceuticals that affect cognitive function. 11.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. 12.Subject who has blood drawn or blood component more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 13.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14.Subject who can't keep the daily records. 15.Subject who is judged as an inappropriate candidate according to the screening data. 16.Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MCI screen (short-term memory, long-term memory) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Pittsburgh Sleep Quality Index,SF-36v2 Japanese version,PHQ-9 Japanese version (Safety evaluation) Vital signs, body measurement(weight,BMI),biochemical tests, hematological tests, adverse events (Exploratory outcomes) Satisfaction With Life Scale Japanese version(SWLS;screening only),Participant Background Questionnaire(screening only) | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed