UMIN-CTR Clinical Trial

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
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 980-0845, 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 980-0845, 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	Tohoku University
Address	468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, 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	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	218
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	Completed
Date of protocol fixation	2018 Year 12 Month 27 Day
Date of IRB	2018 Year 07 Month 06 Day
Anticipated trial start date	2019 Year 02 Month 25 Day
Last follow-up date	2020 Year 03 Month 31 Day
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	2020 Year 08 Month 18 Day

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