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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035830
Receipt No. R000040817
Official scientific title of the study The study on usefulness of the Japanese diet score
Date of disclosure of the study information 2019/02/12
Last modified on 2019/02/10

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Basic information
Official scientific title of the study The study on usefulness of the Japanese diet score
Title of the study (Brief title) The study on usefulness of the Japanese diet score
Region
Japan

Condition
Condition Healthy aduits
Classification by specialty
Medicine in general Geriatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The effect of the nutritional guidance using the Japanese diet score 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
/Meal survey (FFQ, Japanese diet score)
/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 Japanese diet score 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
Name of lead principal investigator Tsuyoshi Tsuduki
Organization Tohoku University
Division name Graduate School of Agricultural Science
Address 468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, Japan
TEL 022-757-4392
Email tsudukit@tohoku.ac.jp

Public contact
Name of contact person Tsuyoshi Tsuduki
Organization Tohoku University
Division name Graduate School of Agricultural Science
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)

Secondary IDs
Secondary IDs YES
Study ID_1 18-A-02
Org. issuing International ID_1 Tohoku University Ethics Committee
Study ID_2 HR-2019-TU04
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 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 04 Day
Anticipated trial start date
2019 Year 03 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 10 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040817

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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