UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049728 |
|---|---|
| Receipt number | R000056639 |
| Scientific Title | Effect of healthy diet on minor health complaints and behavior change |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2024/12/09 09:10:50 |
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Basic information
Public title
Effect of healthy diet on minor health complaints and behavior change
Acronym
Effect of healthy diet on minor health complaints and behavior change
Scientific Title
Effect of healthy diet on minor health complaints and behavior change
Scientific Title:Acronym
Effect of healthy diet on minor health complaints and behavior change
Region
| Japan |
Condition
Condition
minor health complaints
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of healthy diet on minor health complaints and behavior change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
minor health complaints and behavior
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1 week, healthy diet
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy person with minor health complaints
Key exclusion criteria
Exclusio criteria are pregnancy, breast-feeding, those who will alter lifestyle during test, those who have restricted diet, those who have food allergy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Kimoto |
Organization
National Agriculture and Food Research Organization
Division name
Institute of Food Research
Zip code
305-8642
Address
2-1-12, Kannondai, Tsukuba
TEL
029-838-7981
anne@affrc.go.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Kimoto |
Organization
National Agriculture and Food Research Organization
Division name
Institute of Food Research
Zip code
305-8642
Address
2-1-12, Kannondai, Tsukuba
TEL
029-838-7981
Homepage URL
anne@affrc.go.jp
Sponsor or person
Institute
National Agriculture and Food Research Organization
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
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
National Agriculture and Food Research Organization
Address
2-1-12, Kannondai, Tsukuba
Tel
029-838-7981
anne@affrc.go.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
| 2022 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
83
Results
under estimate
Results date posted
| 2024 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adult
Participant flow
Full
Adverse events
None
Outcome measures
minor health complaint
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056639
