UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000020449
Receipt No. 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 (Ver. 6)

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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
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 980-0802
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023629