Unique ID issued by UMIN | UMIN000051463 |
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Receipt number | R000058706 |
Scientific Title | Beneficial Effects of Konjac-derived Glucosylceramide on Cognitive function |
Date of disclosure of the study information | 2023/07/03 |
Last modified on | 2023/12/27 09:13:38 |
Beneficial Effects of Konjac-derived Glucosylceramide on Cognitive function
Beneficial Effects of Konjac-derived Glucosylceramide on Cognitive function
Beneficial Effects of Konjac-derived Glucosylceramide on Cognitive function
Beneficial Effects of Konjac-derived Glucosylceramide on Cognitive function
Japan |
Healthy adult
Adult |
Others
NO
To investigate clinical benefits associated with 24 weeks daily ingestion of konjac-derived glucosylceramide on cognitive function in a randomized, double-blind, placebo-controlled, parallel group study.
Efficacy
Exploratory
Pragmatic
Cognitive assessment (MoCA-J, logical memory I and II of the WMS-R, digit symbol substitution test of the WAIS-IV, S-PA) and blood amyloid-beta composite biomarker after 24 weeks of ingestion.
Mental activity assessment, blood amyloid-beta binding exosomes, blood sphingolipids
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
Central registration
4
Treatment
Food |
Daily ingestion of test food 1 for 24 weeks.
Daily ingestion of test food 2 for 24 weeks.
Daily ingestion of test food 3 for 24 weeks.
Daily ingestion of placebo food for 24 weeks.
60 | years-old | <= |
80 | years-old | > |
Male and Female
1. Subjects who agree to participate in this study with a written informed consent.
2. Japanese males and females between 60 and 80 years old at the time of screening test.
3. Subjects who are aware of their cognitive decline, such as forgetfulness.
4. Subjects with relatively low total MoCA-J score at the time of screening test.
5. Subjects who can carry out cognitive function test, write diary and questionnaire.
1. Subjects whose total MMSE score is <= 23 points.
2. Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease.
3. Subjects with a history or suspected of psychiatric disorder and cerebrovascular disease.
4. Subjects with implantable electronic medical devices.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory diseases, and/or affected with infectious diseases requiring reports to the authorities.
6. Subjects with major surgical history relevant to the digestive system.
7. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
8. Subjects with severe anemia.
9. Pre- or post-menopausal women complaining of obvious physical changes.
10. Subjects with dysphagia.
11. Subjects who may have allergic reactions to drugs, foods or plants (especially gelatin, mango, urushi, pistachio, cashew nut, latex rubber and birch).
12. Subjects who regularly take medicine, functional foods which would affect cognitive function.
13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
14. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
40
1st name | Naoyuki |
Middle name | |
Last name | HONMA |
Hokkaido Information University
Department of Medical Management and Informatics
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
1st name | Naoyuki |
Middle name | |
Last name | HONMA |
Hokkaido Information University
Health Information Science Center
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Hokkaido Information University
Hokkaido University
Other
Japan
The ethics committee of Hokkaido Information University
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
soumu@do-johodai.ac.jp
NO
北海道情報大学 保健センター(北海道)
2023 | Year | 07 | Month | 03 | Day |
Unpublished
No longer recruiting
2023 | Year | 06 | Month | 21 | Day |
2023 | Year | 06 | Month | 21 | Day |
2023 | Year | 07 | Month | 06 | Day |
2024 | Year | 04 | Month | 26 | Day |
2023 | Year | 06 | Month | 27 | Day |
2023 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058706
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