UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035830 |
|---|---|
| Receipt number | R000040817 |
| Scientific Title | The study on usefulness of the Japanese diet score |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2020/08/18 12:27:05 |
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Basic information
Public title
The study on usefulness of the Japanese diet score
Acronym
The study on usefulness of the Japanese diet score
Scientific Title
The study on usefulness of the Japanese diet score
Scientific Title:Acronym
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
| 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
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
tsudukit@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
tsudukit@tohoku.ac.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
222
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
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | 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 | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040817
