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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032270
Receipt No. R000036737
Scientific Title Effectiveness of pyrroloquinone quinone amino acid on mental status of Japanese subjects
Date of disclosure of the study information 2018/04/16
Last modified on 2019/06/10

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Basic information
Public title Effectiveness of pyrroloquinone quinone amino acid on mental status of Japanese subjects
Acronym Effectiveness of pyrroloquinone quinone amino acid on mental status of Japanese subjects
Scientific Title Effectiveness of pyrroloquinone quinone amino acid on mental status of Japanese subjects
Scientific Title:Acronym Effectiveness of pyrroloquinone quinone amino acid on mental status of Japanese subjects
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We checked the cognitive function improvement effect with the PQQ intake.We compared the reaction time with the correct answer rate of the cognitive problem before and after the PQQ intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We compared the reaction time with the correct answer rate of the cognitive problem before and after the PQQ intake. We examined it in the near-infrared light brain function imaging device(NIRS:Near Infra-Red Spectoroscopy) which can observe a bloodstream state of the brain directly.It is the measurement in base line between parallel two groups of PQQ intake group and the placebo food intake group and 12 weeks later.
Key secondary outcomes

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 Treatment
Type of intervention
Food
Interventions/Control_1 The subjects intake pyrroloquinolinquinon(PQQ)20mg per day. We checked their blood and their bloodstream state of brain for base line and 12weeks later.
Interventions/Control_2 The subjects intake placebo food 20mg per day. We checked their blood and their bloodstream state of brain for base line and 12weeks later.
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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Healthy adult
2. It is possible to maintain the day-to-day life.
3. The person who was pamitted the paticipation by the docor.
Key exclusion criteria 1.The person who had a mental disease, the brain functional disorder in the past
2.The person with the cerebrovascular disorder
3.The person who took a drug or a supplement about a brain function or bloodstream improvement within three months before examination start
4.The person with gelatine allergy
5.The pregnant or nursing woman
6.The person who wasn't pamitted the paticipation by the docor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Tnaka
Organization Kagawa Nutrition University
Division name Nutrition Clinic
Zip code 170-8481
Address 3-24-3 Komagome,Toshima,Tokyo.
TEL 03-3918-6181
Email clinic@eiyo.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Kamachi
Organization Kagawa Nutiriton Nuversity
Division name Nutrition Clinic
Zip code 170-8481
Address 3-24-3 Komagome,Toshima,Tokyo.
TEL 03-3918-6181
Homepage URL
Email clinic@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
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 Kagawa Nutrition University
Address 3-21-9 Chiyoda,Sakado,Saitama,Japan
Tel 049-283-2131
Email clinic@eiyo.ac.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
2018 Year 04 Month 16 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 50
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 Terminated
Date of protocol fixation
2016 Year 11 Month 26 Day
Date of IRB
2016 Year 11 Month 26 Day
Anticipated trial start date
2016 Year 11 Month 26 Day
Last follow-up date
2019 Year 06 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 16 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036737

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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