UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041575
Receipt number R000047421
Scientific Title Influence on health consciousness and physical condition by "healthy meal" intake (31244)
Date of disclosure of the study information 2020/09/23
Last modified on 2020/10/12 09:11:45

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Basic information

Public title

Influence on health consciousness and physical condition by "healthy meal" intake (31244)

Acronym

Influence on health consciousness and physical condition by "healthy meal" intake (31244)

Scientific Title

Influence on health consciousness and physical condition by "healthy meal" intake (31244)

Scientific Title:Acronym

Influence on health consciousness and physical condition by "healthy meal" intake (31244)

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 18 to 20 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 and the results of preliminary examination
(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 or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



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 23 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 24 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 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047421


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name