UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021081 |
|---|---|
| Receipt number | R000023709 |
| Scientific Title | Benefit study of traditional Japanese diet 1 |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2020/02/17 17:37:29 |
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Basic information
Public title
Benefit study of traditional Japanese diet 1
Acronym
The effect of Japanese diet on the sleep, stress and metabolism
Scientific Title
Benefit study of traditional Japanese diet 1
Scientific Title:Acronym
The effect of Japanese diet on the sleep, stress and metabolism
Region
| Japan |
Condition
Condition
Healthy volunteers with obesity
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The effect of Japanese diet on the sleep, stress and metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep and Stress Quality-related Questionnaire and measurement Items after four weeks' intervention
Key secondary outcomes
/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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take the test food(1975 Japanese diet) during 4 weeks.
Interventions/Control_2
The subjects take the test food(Modern Japanese diet) 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Aged 20-40 years at informed consent
2) Body-mass index (BMI) 25-30 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
60
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
980-0845
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
980-0845
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 | 02 | Month | 18 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/oby.22448
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/oby.22448
Number of participants that the trial has enrolled
60
Results
The 1975 Japanese diet (JD) group had significantly decreased BMI, fat mass, and levels of low density lipoprotein cholesterol, glycated hemoglobin, and C reactive protein and significantly increased high density lipoprotein cholesterol levels compared with those in the MD group. The intake of a diet with the characteristics of the 1975 JD may have beneficial effects on lipid metabolism in people with overweight and reduce the onset risk of metabolism related disorders, such as obesity and diabetes.
Results date posted
| 2020 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 04 | Month | 15 | Day |
Baseline Characteristics
Subjects with a BMI of 25 or more and less than 30
Participant flow
Using a single blind randomized controlled trial, the modern diet (MD) was compared with the 1975 type JD, which is based on the MD but includes five characteristics of the 1975 JD in an enhanced form. Overweight people were randomly assigned to an MD group (n=30) and a JD group (n=30). The participants consumed test diets that were provided three times a day for 28 days.
Adverse events
None
Outcome measures
Body composition measurements and blood biochemical examinations were performed before and after the test diet intake, and the proportions of change were compared.
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
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 17 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | 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=R000023709
