Study on the effect of food ingredients on the memory of healthy middle-aged and elderly
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000042414
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MCI screen (short-term memory, long-term memory)
- Secondary Outcome Measures
Name Time Method (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)