Unique ID issued by UMIN | UMIN000034459 |
---|---|
Receipt number | R000039247 |
Scientific Title | Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults |
Date of disclosure of the study information | 2020/05/20 |
Last modified on | 2023/04/04 11:51:01 |
Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults
Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults
Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults
Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults
Japan |
Healthy subjects
Adult |
Others
NO
The purpose of this study is to investigate the effects of continuous ingestion of test foods on brain function and body composition in healthy Japanese adults aged 20 to 65 years or younger.
Safety,Efficacy
Cognitrax and task memory tests
BDNF and Overall body composition by In body
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
12-week intake of the containing PQQ 2Na food of 1 capsules a day
2-week intake of the placebo food of 1 capsules a day
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1)Healthy individuals without serious disease
2)Regardless of gender
3)Patients aged 20 years or older to 65 years or younger who voluntarily wish to participate in clinical trials and obtain written consent.
4)Patients who can maintain a constant lifestyle during the study period
5)Subjects being treated for mild chronic illness (e.g., hypertension, hyperlipidemia) may participate in the study at the discretion of the investigator.
6)Patients who have a MMSE score of 24 or more
1)Patients suffering from serious liver and kidney disease, heart disease, respiratory disorders, endocrine disorders, diabetes mellitus, food allergy, drug allergy, cancer, dementia and psychiatric disorders
2)Patients allergic to gelatin
3)Patients who wish to be pregnant, lactating, or pregnant during the study period
4)Patients who have ingested PQQ 2Na within 3 months before the test
5)Patients who are deemed ineligible to participate in the study.
70
1st name | Tomomi |
Middle name | |
Last name | Suzuki |
Mitsubishi Gas Chemical Company, Inc.
Bio Products Team Life Science Division
100-8324
Marunouchi 2-5-2 Mitsubishi Building, Chiyoda-ku, Tokyo 100-8324 Japan
03-3283-4893
tomomi-suzuki@mgc.co.jp
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
81-3-3431-1260
ochitani@huma-rd.co.jp
HUMA R&D CORP
Mitsubishi Gas Chemical Company, Inc.
Profit organization
Ethics Committees of Nihonbashi Egawa Clinic
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
03-5204-0311
jim@medipharma.co.jp
NO
2020 | Year | 05 | Month | 20 | Day |
Unpublished
70
Completed
2018 | Year | 09 | Month | 14 | Day |
2018 | Year | 11 | Month | 29 | Day |
2018 | Year | 10 | Month | 29 | Day |
2019 | Year | 03 | Month | 19 | Day |
2019 | Year | 03 | Month | 27 | Day |
2019 | Year | 05 | Month | 20 | Day |
2023 | Year | 03 | Month | 31 | Day |
2018 | Year | 10 | Month | 12 | Day |
2023 | Year | 04 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039247
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |