UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044556 |
|---|---|
| Receipt number | R000050751 |
| Scientific Title | The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2022/12/13 12:24:04 |
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Basic information
Public title
The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders
Acronym
The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders
Scientific Title
The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders
Scientific Title:Acronym
The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of improving effects of mild physical and mental disorders by ingesting potatoes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vas questionaire
eye strain, sleep quality, stress, constipation and fatigue
Visceral fat area
Key secondary outcomes
Blood components, brain waves, heart beat
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects ingest the placebo meal for eight weeks
Interventions/Control_2
The subjects ingest the active meal for eight weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Individuals who understand the purpose and contents of the experiment
2)Healthy male and female between 20 and 79 years old
3)Subjects who not are contracting or treating serious cerebrovascular disease and/or heart disease and/or liver diseases and/or digestive disease and/or infectious diseases that need to be reported
Key exclusion criteria
1)Pregnant women, or women with intending to become pregnant, and lactating woman
2)Individuals judged by the doctor to be unsuitable
3)Person who donated more than 400 ml of blood within 3 months prior to the study
4)Individuals participating or intending to participate in a drug administration test
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ito |
Organization
Univercity of Nagasaki
Division name
Regional Partner Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135500
Homepage URL
hito@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Univercity of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel
0958135216
katanaka@sun.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
| 2021 | Year | 06 | 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
60
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
| 2021 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050751
