UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032270 |
|---|---|
| Receipt number | 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 11:38:26 |
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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
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
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
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
Kagawa Nutrition University
Address
3-21-9 Chiyoda,Sakado,Saitama,Japan
Tel
049-283-2131
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036737
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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