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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041576
Receipt No. R000047467
Scientific Title Influence on health consciousness and physical condition by "healthy meal" intake (31245)
Date of disclosure of the study information 2020/09/01
Last modified on 2020/09/09

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Basic information
Public title Influence on health consciousness and physical condition by "healthy meal" intake (31245)
Acronym Influence on health consciousness and physical condition by "healthy meal" intake (31245)
Scientific Title Influence on health consciousness and physical condition by "healthy meal" intake (31245)
Scientific Title:Acronym Influence on health consciousness and physical condition by "healthy meal" intake (31245)
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the change on health consciousness and physical condition by "healthy meal" intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective indicator, Questionnaires
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake "healthy meal" for 38 to 40 days
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who agrees in writing to study participation and can inspect on predetermined inspection day
Key exclusion criteria (1) Subjects who are unable to continuously intake "healthy meal" during intake period
(2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(3) Subjects who are judged as unsuitable for the study based on the medical history
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects who have difficulty in treatment by participating in the study
(6) Subjects who are receiving treatment or use equipment that affects the examination
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects who have participated in other clinical study prior to the current study
(9) Subjects who intend to become pregnant or lactating
(10) Subjects who judged as unsuitable for the study by the investigator for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kondo
Organization Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name none
Zip code 169-0072
Address Daito Bldg., 1-11-3, Okubo, Shinjuku-ku, Tokyo
TEL 03-6233-8583
Email h.kondo@meiseikai-cl.com

Public contact
Name of contact person
1st name Hiroyasu
Middle name
Last name Shimada
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code 150-0021
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email h.shimada@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization non-disclosure
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hitachi Omika Hospital
Address 2-22-30, omika-cho, hitachi-shi, Ibaraki
Tel 029-232-8788
Email masaki.ohata@medical-art.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2020 Year 07 Month 31 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 09 Month 02 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 27 Day
Last modified on
2020 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047467

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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