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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035814
Receipt No. R000040802
Scientific Title The study on health benefit of the Japanese diet
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/08

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Basic information
Public title The study on health benefit of the Japanese diet
Acronym The study on health benefit of the Japanese diet
Scientific Title The study on health benefit of the Japanese diet
Scientific Title:Acronym The study on health benefit of the Japanese diet
Region
Japan

Condition
Condition Healthy aduits
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The effect of the Japanese diet on inflammation, aging, metabolism, intestinal gut microbiota, and stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood inflammation parameters (CRP)(Measured 0, 6, 12 months after the start of the test)
Key secondary outcomes /Body weight, body mass index, visceral fat mass
/Hematological and biochemical evaluation by blood examination, bioactive molecules
/Intestinal bacteria
/Aging marker (G-tail telomere)
/Stress Quality-related Questionnaire and measurement Items

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Subjects receive the nutritional guidance of characteristics of the 1975 Japanese diet and continue eating along the guidance for one year.
Interventions/Control_2 Subjects receive general nutritional guidance and continued eating along the guidance for one year.
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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged 50-75 years at informed consent
2) Body-mass index (BMI) 18.5-30 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 230

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Tsuduki
Organization Tohoku University
Division name Graduate School of Agricultural Science
Zip code
Address 468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, Japan
TEL 022-757-4392
Email tsudukit@tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tsuyoshi Tsuduki
Organization Tohoku University
Division name Graduate School of Agricultural Science
Zip code
Address 468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, 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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 08 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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