UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054159 |
|---|---|
| Receipt number | R000061842 |
| Scientific Title | Research on the effects of test food intake on physical and mental health in healthy women:a randomized, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/15 18:47:57 |
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Basic information
Public title
Research on the effects of test food intake on physical and mental health in healthy women
Acronym
Research on the effects of test food intake on physical and mental health in healthy women
Scientific Title
Research on the effects of test food intake on physical and mental health in healthy women:a randomized, double-blind, parallel-group comparison study
Scientific Title:Acronym
Research on the effects of test food intake on physical and mental health in healthy women:a randomized, double-blind, parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of test food intake on physical and mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation status (according to Roma IV standards)
Time of evaluation: Before intake of test food and 2 weeks, 4 weeks after intake
Key secondary outcomes
pittsburgh sleep quality index:PSQI
Indicators from mental health surveys
Indicators from health-related QOL surveys
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake period: 4 weeks
Test food: grain
Intake method: Take the prescribed amount twice a day at home.
It is acceptable even if there are days when the subject cannot take it due to unavoidable circumstances.
Interventions/Control_2
Intake period: 4 weeks
Test food: grain
Intake method: Take the prescribed amount twice a day at home.
It is acceptable even if there are days when the subject cannot take it due to unavoidable circumstances.
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy Japanese adult female
Key exclusion criteria
1. Those with barley allergy
2. Those with wheat allergy (consider cross-reactivity)
3. Those who regularly use drugs or supplements for bowel movements, sleep, or mental health.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | HONDA |
Organization
Kobe Women's University
Division name
Department of Health, Sports, and Nutrition, Faculty of Health and Welfare
Zip code
660-0861
Address
4-7-2, Minatojima-nakamachi, Kobe Chuo-ku,Hyogo 650-0046, Japan
TEL
078-303-4700
mhonda@kwjc.kobe-wu.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | HONDA |
Organization
Kobe Women's University
Division name
Department of Health, Sports, and Nutrition, Faculty of Health and Welfare
Zip code
650-0046
Address
4-7-2, Minatojima-nakamachi, Kobe Chuo-ku,Hyogo 650-0046, Japan
TEL
078-303-4700
Homepage URL
mhonda@kwjc.kobe-wu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Kobe Women's University / Kobe Women's Junior College Research Ethics Committee for Humans
Address
4-7-2, Minatojima-nakamachi, Kobe Chuo-ku,Hyogo 650-0046, Japan
Tel
078-303-4700
mhonda@kwjc.kobe-wu.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
| 2024 | Year | 04 | Month | 15 | 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
65
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
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
