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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029405
Receipt No. R000033603
Scientific Title Central nervous system and autonomic nervous system effects by functional foods
Date of disclosure of the study information 2017/10/04
Last modified on 2019/04/05

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Basic information
Public title Central nervous system and autonomic nervous system effects by functional foods
Acronym Central nervous system and autonomic nervous system effects by functional foods
Scientific Title Central nervous system and autonomic nervous system effects by functional foods
Scientific Title:Acronym Central nervous system and autonomic nervous system effects by functional foods
Region
Japan

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

Objectives
Narrative objectives1 This study aims to examine the effects of functional foods on the central nervous system and the autonomic nervous system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood Pressure, Electrocardiogram
Blood flow, Electroencephalogram
Electrogastrograph,
Electromyography
Key secondary outcomes POMS,SDS,
Hormone test, stress test,
Anti-fatigue test, State Anxiety(STAI)

Base
Study type Interventional

Study design
Basic design Cross-over
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 1)Oral ingestion of functional food
2)washout
3)Oral ingestion of control food
Interventions/Control_2 1)Oral ingestion of control food
2)washout
3)Oral ingestion of functional food
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1.Japanese males and females aged 20-59 years
2.Non-smokers
3.Individuals whose written informed consent has been obtained
Key exclusion criteria 1. Person having a disease
2. Person who takes medicine
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshimitsu
Middle name
Last name Okita
Organization Shizuoka University
Division name Graduate School of Integrated Science and Technology
Zip code 432-8011
Address 3-5-1 Johoku, Naka-ku, Hamamatsu
TEL 053-478-1353
Email okita.yoshimitsu@shizuoka.ac.jp

Public contact
Name of contact person
1st name Yoshimitsu
Middle name
Last name Okita
Organization Shizuoka University
Division name Graduate School of Integrated Science and Technology
Zip code 432-8011
Address 3-5-1 Johoku, Naka-ku, Hamamatsu
TEL 053-478-1353
Homepage URL
Email okita.yoshimitsu@shizuoka.ac.jp

Sponsor
Institute Shizuoka University
Institute
Department

Funding Source
Organization Shizuoka University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shizuoka University
Address 3-5-1 Johoku, Naka-ku, Hamamatsu
Tel 0534781353
Email okita.yoshimitsu@shizuoka.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
2017 Year 10 Month 04 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
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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 29 Day
Date of IRB
2017 Year 10 Month 01 Day
Anticipated trial start date
2017 Year 10 Month 03 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 03 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033603

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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