UMIN ID: UMIN000036999
Registered date:05/06/2020
Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy adults |
| Date of first enrollment | 2019/06/07 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Take 3 tablets of Phosphatidylserine-containing supplement daily for 6 weeks Take 3 placebo tablets daily for 6 weeks |
Outcome(s)
| Primary Outcome | Evaluate cognitive function using Mini Mental State Examination (MMSE) |
|---|---|
| Secondary Outcome | Standard verbal paired-associate learning test, Benton visual retention test |
Key inclusion & exclusion criteria
| Age minimum | 60years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2)persons who have changed their habitats to take supplements within past 4 weeks. (3)persons who work in night shift or in day and night shift (4)persons who have been treated their illness or prevention in a clinic at their informed consent (5)persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6)persons with the medical histories of alcoholism or drug dependence (7)persons who might be developed allergic reaction to foods. (8)persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9)persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10)persons who will not be judged suitable to the participants by the investigator |
Related Information
| Primary Sponsor | Faculty of Humanity-Oriented Science and Engineering, Kindai University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Outgoing Integrated Medical Association |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ohnuki Koichiro |
| Address | 11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan Japan 820-0011 |
| Telephone | 0948-22-5655 |
| ohnuki@fuk.kindai.ac.jp | |
| Affiliation | Faculty of Humanity-Oriented Science and Engineering, Kindai University Food Functional Science Laboratory |
| scientific contact | |
| Name | Koichiro Ohnuki |
| Address | 11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan Japan |
| Telephone | 0948-22-5655 |
| ohnuki@fuk.kindai.ac.jp | |
| Affiliation | Faculty of Humanity-Oriented Science and Engineering, Kindai University Food Functional Science Laboratory |