UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040244 |
|---|---|
| Receipt number | R000045885 |
| Scientific Title | Brain function improving material pyrroloquinoline quinone (PQQ) functional confirmation test |
| Date of disclosure of the study information | 2021/05/15 |
| Last modified on | 2022/07/01 15:49:01 |
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Basic information
Public title
Brain function improving material pyrroloquinoline quinone (PQQ) functional confirmation test
Acronym
PQQ clinical trial
Scientific Title
Brain function improving material pyrroloquinoline quinone (PQQ) functional confirmation test
Scientific Title:Acronym
PQQ clinical trial
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Geriatrics |
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of PQQ-containing foods on cognitive and memory functions, a randomized double-blind study (RCT) will be conducted in healthy men and women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax
Key secondary outcomes
Forgetfulness questionnaire, MMSE-J
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake the test food (PQQ blended food) for 12 weeks
Interventions/Control_2
Intake the control food for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females between the ages of 40 and less than 80 at the time of obtaining consent to participate in the test
2)Those who do not meet the diagnostic criteria for dementia
3)Those who feel more forgetful than before
4)Healthy persons who are not currently being treated for any serious illness
5)Those who can visit the designated facility on the scheduled visit date
6)Those who fully understand the purpose and content of this test and have agreed in writing
Key exclusion criteria
1)Those who regularly use health foods (including supplements that have antioxidant effects and blood flow improvement effects) for the purpose of improving brain function decline or forgetfulness
2)Those who have MMSE-J score of 23 or less
3)Difficulty in participating in the trial due to liver, kidney or heart disease, respiratory, endocrine, metabolic or neurological disorders, disturbance of consciousness, diabetes mellitus (according to the Japan Diabetes Society criteria), or other disease
4)Those who have undergone treatment inpatient surgery for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion and head injury
5)Those who are taking medicines (antipsychotics, anxiolytics, antidepressants, anti-Parkinson's drugs, antidepressants, antiepileptics, anticoagulants, etc.) that may affect the study
6)Allergies related to the investigational product
7)History of hepatitis, current history, cardiovascular disease, severe anemia
8)Previous experience of poor or worsened health after giving a blood sample
9)Blood donations 200 mL or more in the month before the trial or have plans for making a blood donation 200 mL or more during the trial period
10)Participation in another clinical trial, whether ongoing or within the last four weeks
11)Heavy drinkers and smokers
12)Extremely irregular dietary patterns
13)Those who do not wish to provide their consent to the details of the trial explained to them in advance
14)Those who have taken psychological tests such as psychological tests in the hospital within the past 3 months
15)Those who judged that examination responsible doctor is not appropriate for this study participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Division
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Akanuma Surgery Clinic
Clinical Trials Division
Institute
Department
Personal name
Funding Source
Organization
Ryusendo Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Akanuma Surgery Clinic
Address
6-14-1 Ishiyama 2-jo, Minami-ku, Sapporo-shi, Hokkaido 005-0842, Japan
Tel
011-591-1777
s-ito@kyowa-t.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/07315724.2021.1962770
Number of participants that the trial has enrolled
61
Results
A significant difference was observed in the primary outcome.
Results date posted
| 2022 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Japanese adult
Participant flow
61 participants completed and 58 subjects were incorporated into the analyses.
Adverse events
No adverse effect reported
Outcome measures
Cognitrax
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045885
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| Registered date | File name |
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