UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029405 |
|---|---|
| Receipt number | 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 | 2023/04/10 11:40:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
okita.yoshimitsu@shizuoka.ac.jp
Sponsor or person
Institute
Shizuoka University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033603
