UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054969 |
|---|---|
| Receipt number | R000062777 |
| Scientific Title | A Randomized, Double-Blind, Parallel Group Study on the Effect of Continuous Consumption of Nutritionally Balanced "Bento" on Psychosomatic Disorders |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2026/01/16 17:17:34 |
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Basic information
Public title
A Randomized, Double-Blind, Parallel Group Study on the Effect of Continuous Consumption of Nutritionally Balanced "Bento" on Psychosomatic Disorders
Acronym
A Randomized, Double-Blind, Parallel Group Study on the Effect of Continuous Consumption of Nutritionally Balanced "Bento" on Psychosomatic Disorders
Scientific Title
A Randomized, Double-Blind, Parallel Group Study on the Effect of Continuous Consumption of Nutritionally Balanced "Bento" on Psychosomatic Disorders
Scientific Title:Acronym
A Randomized, Double-Blind, Parallel Group Study on the Effect of Continuous Consumption of Nutritionally Balanced "Bento" on Psychosomatic Disorders
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on psychosomatic disorders of continuous consumption of two nutritionally balanced meals ("Bento") for 12 weeks in a randomized, double-blind, parallel-group study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GHQ60
Key secondary outcomes
SF-12, physical condition questionnaire, skin test, sleep-wake rhythm, intestinal microflora analysis, capillary examination, body composition, vital signs, blood tests, urine test, BDHQ, Questionnaire on food consciousness and food behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
low-salt meal
Interventions/Control_2
low-salt Japanese meal
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects with informed consent for the study participation.
2. Japanese male and female students between the ages of 18 and 30
3. Those with relatively low adherence score for the food guide
Key exclusion criteria
1. those who are under medical treatment, medication, or lifestyle guidance by a physician for schizophrenia, depression, mania, neurological disorders, sleep disorders, or chronic fatigue syndrome
2. who are using metal medical devices implanted in the body (pacemakers, implantable defibrillators, artificial bone heads, plates, etc.)
3. who are receiving nutritional guidance at a medical institution
4. who are undergoing treatment or taking medication for liver disease, renal disease, gastrointestinal disease, or lifestyle-related diseases (hypertension, hyperglycemia, hyperuricemia, cardiac disease, high cholesterol, etc.)
5. who cannot continue to consume the test food for reasons such as the possibility of showing allergic symptoms
6. who is planning to make a major lifestyle change during the intake period of the test food
7. who are participating in other clinical trials, observational studies, clinical trials, or home-use tests between 4 weeks prior to the start and the end of the intake of the test food
8. who are otherwise deemed ineligible by the Principal Investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nishihira |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nishihira |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization, bio-oriented technology Research Advancement Institution
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba
National Agriculture and Food Research Organization
National Institute of Advanced Industrial Science and Technology
KOSE Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
北海道情報大学（北海道）、筑波大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
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
| 2024 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062777
