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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040244
Receipt No. 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 2020/11/11

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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
Email 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
Email m.takahashi@ryusendo.co.jp

Sponsor
Institute Akanuma Surgery Clinic
Clinical Trials Division
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
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
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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