UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034459
Receipt number R000039247
Scientific Title Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults
Date of disclosure of the study information 2020/05/20
Last modified on 2023/04/04 11:51:01

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Basic information

Public title

Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults

Acronym

Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults

Scientific Title

Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults

Scientific Title:Acronym

Validation Study of Pyrroloquinoline quinone disodium salt (PQQ 2Na) for Improvement of Brain Function in Healthy Adults

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effects of continuous ingestion of test foods on brain function and body composition in healthy Japanese adults aged 20 to 65 years or younger.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitrax and task memory tests

Key secondary outcomes

BDNF and Overall body composition by In body


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week intake of the containing PQQ 2Na food of 1 capsules a day

Interventions/Control_2

2-week intake of the placebo food of 1 capsules a day

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Healthy individuals without serious disease
2)Regardless of gender
3)Patients aged 20 years or older to 65 years or younger who voluntarily wish to participate in clinical trials and obtain written consent.
4)Patients who can maintain a constant lifestyle during the study period
5)Subjects being treated for mild chronic illness (e.g., hypertension, hyperlipidemia) may participate in the study at the discretion of the investigator.
6)Patients who have a MMSE score of 24 or more

Key exclusion criteria

1)Patients suffering from serious liver and kidney disease, heart disease, respiratory disorders, endocrine disorders, diabetes mellitus, food allergy, drug allergy, cancer, dementia and psychiatric disorders
2)Patients allergic to gelatin
3)Patients who wish to be pregnant, lactating, or pregnant during the study period
4)Patients who have ingested PQQ 2Na within 3 months before the test
5)Patients who are deemed ineligible to participate in the study.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Tomomi
Middle name
Last name Suzuki

Organization

Mitsubishi Gas Chemical Company, Inc.

Division name

Bio Products Team Life Science Division

Zip code

100-8324

Address

Marunouchi 2-5-2 Mitsubishi Building, Chiyoda-ku, Tokyo 100-8324 Japan

TEL

03-3283-4893

Email

tomomi-suzuki@mgc.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL


Email

ochitani@huma-rd.co.jp


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Gas Chemical Company, Inc.

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

Ethics Committees of Nihonbashi Egawa Clinic

Address

2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan

Tel

03-5204-0311

Email

jim@medipharma.co.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

2020 Year 05 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

70

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

2018 Year 09 Month 14 Day

Date of IRB

2018 Year 11 Month 29 Day

Anticipated trial start date

2018 Year 10 Month 29 Day

Last follow-up date

2019 Year 03 Month 19 Day

Date of closure to data entry

2019 Year 03 Month 27 Day

Date trial data considered complete

2019 Year 05 Month 20 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 10 Month 12 Day

Last modified on

2023 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039247


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name