UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000021081
Receipt No. 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 (Ver. 9)

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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
Email 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
Email tsudukit@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023709