UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020449 |
|---|---|
| Receipt number | R000023629 |
| Scientific Title | Benefit study of traditional Japanese diet 2 |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2020/02/17 17:51:40 |
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Basic information
Public title
Benefit study of traditional Japanese diet 2
Acronym
The effect of Japanese diet on the sleep, stress, motor function and metabolism
Scientific Title
Benefit study of traditional Japanese diet 2
Scientific Title:Acronym
The effect of Japanese diet on the sleep, stress, motor function and metabolism
Region
| Japan |
Condition
Condition
Healthy aduits
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The effect of Japanese diet on the sleep, stress, motor function and metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic athletic ability test (shuttle run, standing triple jump, throwing medicine ball)
Key secondary outcomes
/Sleep and Stress Quality-related Questionnaire and measurement Items
/Body weight, body mass index, visceral fat mass
/Hematological and biochemical evaluation by blood examination, bioactive molecules
/Intestinal bacteria
/Gene expression changes and epigenetic changes in blood cells
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects take the test food(1975 Japanese diet) and perform the exercise three times a week [moderate of more than 1 hour] during 4 weeks.
Interventions/Control_2
The subjects take the test food(Modern Japanese diet) and perform the exercise three times a week [moderate of more than 1 hour] during 4 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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 20-40 years at informed consent
2) Body-mass index (BMI) 18.5-25 kg/m2
3) Obtained written informed consent from the subjects for the study participation
Key exclusion criteria
1) Pregnancy, nursing or planning to become pregnant during the study (female only)
2) Any other significant medical conditions
3) Uncontrolled metabolic syndrome
4) Severe allergies
5) Participation in other clinical trials at enrollment
6) Any other considered by a study physician to be inappropriate for inclusion
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tsuduki |
Organization
Tohoku University
Division name
Graduate School of Agricultural Science
Zip code
980-0802
Address
468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0802, Japan
TEL
022-757-4392
tsudukit@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tsuduki |
Organization
Tohoku University
Division name
Graduate School of Agricultural Science
Zip code
980-0802
Address
468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0802, Japan
TEL
022-757-4392
Homepage URL
tsudukit@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Ethics Committee
Address
468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0802, Japan
Tel
022-757-4392
tsudukit@tohoku.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
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jos/67/5/67_ess17259/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jos/67/5/67_ess17259/_article
Number of participants that the trial has enrolled
32
Results
Body weight, body fat percentage, body fat mass, serum triglyceride level, and serum low-density lipoprotein cholesterol level were significantly decreased and serum high-density lipoprotein cholesterol and serum magnesium levels were significantly increased in 1975 Japanese diet group. These results showed that a diet with the characteristics of the 1975 Japanese diet has a beneficial effect on lipid metabolic parameters.
Results date posted
| 2020 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects aged 20-29 years old
Participant flow
Subjects aged 20~29 years old were randomly assigned to the MD (n=16) and JD (n=16) groups. Each subject consumed the diet three times a day for 28 days.
Adverse events
None
Outcome measures
Changes in physical conditions, including body composition and blood biochemistry, from before to after the study period were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 02 | 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
| 2016 | Year | 01 | Month | 06 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023629
