UMIN-CTR Clinical Trial

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