A clinical study for evaluating the effects of intake of test food on cognitive function: A randomized, double-blind, placebo-controlled, parallel-group comparative method
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000052060
- Lead Sponsor
- EP Mediate Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 150
Not provided
Subjects (1) with an MMSE score of <=23 (2) who have difficulty distinguishing colors and performing cognitive tests (3) with poor eyesight (4) with poor hearing (5) who have difficulty operating a computer (6) who cannot answer online survey (7) who have or have a history of dementia, mental disease, etc. or who are suspected (8) who have or have a history of drug or alcohol dependence (9) who have a menopausal disorder (10) who have or have a history of serious illness (11) who take medicines that may affect the research (12) who may develop allergies (13) who continuously take health foods that may affect cognitive function (14) who continuously take health foods that may affect blood biomarkers and cannot stop during the study (15) who continuously take foods containing a lot of lactic acid bacteria, etc. or medicines that may affect the intestinal environment (16) who are lactose intolerant or prone to diarrhea caused by dairy products (17) who are prone to diarrhea due to alcohol intake (18) who have diarrhea frequently (19) who have irregular lifestyle habits multiple times during the study (20) who plan to change their lifestyle during the study (21) who smoke more than 21 /day (22) who regularly take too much alcohol (23) who have participated in other study within a month before the consent or who plan to participate in other study during the study (24) who have taken a cognitive test conducted in this study within 3 months before the test, or who plan to take a cognitive test during the study (25) who donated or received blood transfusion within 3 months before the screening test, or donated blood components within 2 weeks before the test (26) who are judged to be unsuitable from the lifestyle questionnaire (27) who are judged to be unsuitable based on the results of clinical or physical examination (28) who are judged to be unsuitable by doctor for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive function tests
- Secondary Outcome Measures
Name Time Method Blood biomarkers (antioxidant, inflammation, glucose metabolism, lipid metabolism) Subjective psychological assessments