UMIN-CTR Clinical Trial

Basic information
Public title	Safety confirmation test of pyrroloquinoline quinone disodium salt-containing food
Acronym	Safety confirmation test of pyrroloquinoline quinone disodium salt-containing food
Scientific Title	Safety confirmation test of pyrroloquinoline quinone disodium salt-containing food
Scientific Title:Acronym	Safety confirmation test of pyrroloquinoline quinone disodium salt-containing food
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of pyrroloquinoline quinone disodium salt-containing food
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Doctor's questions, Physiological test, Clinical examination, Adverse event
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Pyrroloquinoline quinone disodium salt-containing food, 4 weeks excessive consumption
Interventions/Control_2
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy adult males and females between the ages of 40 and less than 80 (2)Those with a BMI of less than 30 (3)Those whose written informed consent have been obtained
Key exclusion criteria	(1)Those with a history of hepatic disease, renal disease, gastrointestinal disease, etc., or any other disease that may affect the results of this study, or those with a history of surgery (2)Those who have undergone hospitalization for treatment due to stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion, or head trauma (3)Those with abnormal liver and renal function test values (4)Those who have a disease currently being treated (5)Those with food and drug allergies (6)Those with anemia (7)Previous experience of poor or worsened health after giving a blood sample (8)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 (9)Those who play intense sports and who are on a diet (10)Those who have smoking habits (11)Extremely irregular dietary patterns (12)Those who regularly use health foods (including supplements with antioxidant or blood flow improving effects) for the purpose of decreasing brain function or improving memory loss (13)Those who are taking medicines (antipsychotics, anxiolytics, etc.) that may affect the study (14)Those who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and designated quasi-drugs during the test period (15)Those who continuously take medicines (including OTC and prescription medicines) (16)Heavy drinkers, or those who can't stop drinking from the day before the test until the day (17)Those who have been pregnant or those who have a plan to become pregnant or breast feed during the study period (18)Those who are participating in or will be participating in other clinical trials at the start of this study, and those within 4 weeks after the end (19)Those who judged that examination responsible doctor is not appropriate for this study participation
Target sample size	23

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	Oneness support Co., Ltd.
Institute
Department

Funding Source
Organization	Ryusendo Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Miura Clinic, Medical Corporation Kanonkai IRB
Address	9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka 530-0044, Japan
Tel	06-6135-5200
Email	mterashima@miura-cl.jp

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	2022 Year 06 Month 20 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	2021 Year 05 Month 11 Day
Date of IRB	2021 Year 05 Month 20 Day
Anticipated trial start date	2021 Year 06 Month 16 Day
Last follow-up date	2021 Year 08 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 03 Day
Last modified on	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050578

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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