UMIN-CTR Clinical Trial

Basic information
Public title	Influence on health consciousness and physical condition by "healthy meal" intake
Acronym	Influence on health consciousness and physical condition by "healthy meal" intake
Scientific Title	Influence on health consciousness and physical condition by "healthy meal" intake
Scientific Title:Acronym	Influence on health consciousness and physical condition by "healthy meal" intake
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 17 to 19 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 judged as unsuitable for the study based on the results of lifestyle questionnaire (2) Subjects who are judged as unsuitable for the study based on the medical history (3) Subjects having possibilities for emerging allergy related to the study (4) Subjects who have difficulty in treatment by participating in the study (5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (6) Subjects who have participated in other clinical study prior to the current study (7) Subjects who intend to become pregnant or lactating (8) Subjects who judged as unsuitable for the study by the investigator for other reasons
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Jiro Middle name Last name Saito
Organization	Medical Station Clinic
Division name	None
Zip code	152-0004
Address	3-12-8, Takaban, Meguro-ku, Tokyo
TEL	03-6452-2712
Email	info@med-station.jp

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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	2019 Year 08 Month 06 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	84
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	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 07 Month 25 Day
Anticipated trial start date	2019 Year 08 Month 07 Day
Last follow-up date	2019 Year 12 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 08 Month 05 Day
Last modified on	2020 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042867