UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045885