UMIN-ICDS Clinical Trial

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

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Doctor's questions, Physiological test, Clinical examination, Adverse event

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Oneness support Co., Ltd.

Institute

Department

Personal name

Organization

Ryusendo Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

06

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2021

Year

06

Month

03

Day

Last modified on

2022

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050578