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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034459
Receipt No. 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 2020/01/30

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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 Tomokazu
Middle name
Last name Tachikawa
Organization Mitsubishi Gas Chemical Company, Inc.
Division name Planning and Development Department, Natural Gas Chemicals Company
Zip code 100-8324
Address Marunouchi 2-5-2 Mitsubishi Building, Chiyoda-ku, Tokyo 100-8324 Japan
TEL 03-3283-4893
Email tomokazu-tachikawa@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
Institute HUMA R&D CORP
Institute
Department

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 No longer recruiting
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
2020 Year 05 Month 20 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 12 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.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


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